iMedi.co.uk

Boots Ibuprofen 3 Months Plus 100mg/5ml Oral Suspension Strawberry Flavour

Document: leaflet MAH BRAND_PL 00014-0859 change

148 mm

Information for the user


Ibuprofen 3 Months Plus 100 mg/5 ml Oral Suspension Strawberry Flavour

Read all of this leaflet carefully because it contains important information for you.



270 mm


This medicine is available without prescription to treat minor conditions. However, you still need to give it carefully to get the best results from it.

•    Keep this leaflet, you may need to read it again

•    Ask your pharmacist if you need more information or advice

•    The leaflet is written in terms of giving this medicine to your child, but if you are an adult who is intending to take this medicine yourself the information in this leaflet will apply to you as well

What this medicine is for

This medicine contains Ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which act to relieve pain, swelling (inflammation) and reduce fever. It can be used for the fast, effective relief of mild to moderate pain such as teething pain, toothache, earache, sore throat, headaches and minor aches and sprains. It can also be used to relieve the symptoms of colds and flu and to reduce fever, including fever after vaccination at 3 months of age.

Before you give this medicine

This medicine can be given to children from the age of 3 months. However, some children should not be given this medicine or you should seek the advice of their pharmacist or doctor first.

XDo not give:

   If your child is under 3 months old, or weighs less than 5 kg

•    If your child has a stomach ulcer, perforation or bleeding, or has had one twice or more in the past

•    If your child has had perforation or a bleeding stomach after taking a non-steroidal anti-inflammatory medicine (your child may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in their stools or passed black tarry stools)

   If your child is allergic to ibuprofen or any other ingredients in the product, aspirin or other non-steroidal anti-inflammatory medicines (your child has ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)

•    If your child has severe heart, kidney or liver failure

•    If your child is taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines (aspirin should not generally be given to children under 16, but doctors may occasionally prescribe it)

•    If your child has an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol liquid)

Other important information

Risk of heart attack or stroke:

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

? Talk to your pharmacist or doctor:

•    If your child has asthma, a history of asthma or other allergic disease

•    If your child has bowel problems, or Crohn's Disease

•    If your child has other kidney, heart or liver problems (see above)

•    If your child has connective tissue disorders such as SLE (Systemic Lupus Erythematosus)

•    If your child has chickenpox

•    If your child is on a low salt (sodium) diet (this medicine contains 11 mg of sodium per 5 ml spoonful)

•    If your child is dehydrated - they may get kidney problems

•    If your child has heart problems including heart failure, angina (chest pain), or has had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries),


or any kind of stroke (including 'mini-stroke' or transient ischaemic attack "TIA") - see 'Risk of heart attack or stroke' under “Other important information”

•    If your child has high blood pressure, diabetes, high cholesterol, has a family history of heart disease or stroke

If your child takes other medicines

Before you give this medicine, make sure that you tell your doctor or pharmacist about ANY other medicines you might be giving to the child at the same time. Ibuprofen may affect or be affected by some other medicines. For example:

•    Other pain killers (including NSAIDs)

•    Aspirin 75 mg (to prevent heart attacks or strokes) - the protection may be reduced when you take ibuprofen

•    Medicines to thin the blood (e.g. warfarin, ticlopidine)

•    Water tablets (diuretics)

•    Medicines to treat high blood pressure (e.g. ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan), medicines for heart problems

•    Corticosteroids (for pain and swelling)

•    Lithium (for bipolar disorder)

•    Methotrexate (for cancer, psoriasis or rheumatism)

•    Zidovudine (for HIV infection)

•    Quinolone antibiotics (for infection)

•    Medicines for depression (including selective serotonin re-uptake inhibitors)

•    Ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or rheumatism)

Some other medicines may also affect or be affected by the treatment of ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before your child uses this medicine with any other medicines, including herbal and homeopathic remedies.

Other information

Information about some of the ingredients:

Maltitol liquid may have a mild laxative effect. Each 5 ml spoonful contains 2.1 g maltitol. This provides 5 kcal per 5 ml spoonful. Information for adults intending to take this medicine

All the information in this leaflet applies to you as well.

If you are elderly you may be more likely to have some of the possible side effects listed laterj in the leaflet.

If you have had a stroke, have heart problems, you smoke, have high blood pressure, high cholesterol or diabetes talk to your pharmacist or doctor before you take this medicine (see 'Risk of heart attack or stroke' above).

Pregnancy: Do not take this medicine if you are in the last 3 months of pregnancy. Talk to your pharmacist or doctor if you are in the first 6 months of pregnancy.

Breastfeeding: Talk to your pharmacist or doctor before you take this medicine.

If you are a woman of childbearing age

taking this medicine, it may reduce your ability to become pregnant. This effect will be reversed on stopping the medicine.

Do not take this medicine if you have taken mifepristone (for termination of pregnancy) in the last 12 days.

/How to give this medicine

Check the cap seal is not broken before first use. If it is, do not give the medicine.

It is important to shake the bottle for at least 10 seconds before use.

Always use the syringe supplied with the pack. The

Bean be used to measure 2.5 ml or 5 ml by j the liquid to the correct mark on the syringe.


"Givelhis medicine to your chifcTto swallow.

Age

How much

How often

3 months up to 6 months weighing over 5 kg

2.5 ml

3 times in 24 hours

6 months up to 1 year

2.5 ml

3 to 4 times in 24 hours

1 year up to 4 years

5 ml

3 times in 24 hours

4 years up to 7 years

7.5 ml

3 times in 24 hours

7 years up to 10 years

10 ml

3 times in 24 hours

10 years up to 12 years

15 ml

3 times in 24 hours

Don't give more often than every 4 hours


Give the lowest amount for the shortest possible time to relieve the symptoms.

For infants aged 3 to 5 months, if symptoms worsen or do not go away within 24 hours talk to your doctor.

For a child of 6 months of age and over, if

this medicinal product is required for more than 3 days, or if symptoms worsen talk to your doctor.

For fever relief after vaccination at 3 months of age: Give 2.5ml. Give a second 2.5 ml after 6 hours, if you need to. Don't give any more medicine after second 2.5 ml. See a doctor if fever continues.

Do not give more than the amount recommended above.

Do not give to children under 3 months of age. Directions for using the syringe:

1.    Shake the bottle for at least 10 seconds before use.

2.    Push the syringe firmly into the plug (hole) in the neck of the bottle.

3.    To fill the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark (2.5 ml or 5 ml) on the syringe.

4.    Turn the bottle the right way up, and then gently twist the syringe to remove from the bottle plug.

5.    Place the end of the syringe into the child’s mouth, normally to the side of the mouth between the gums and cheek. Press the plunger down to slowly and gently release the medicine.

6.    If the table above advises you to give more than 5 ml of the medicine, repeat steps 2 to 5 to give your child the correct amount of medicine.

After use replace the cap on the top of the bottle tightly. Store all medicines out of the sight and reach of children.

Wash the syringe in warm water and allow to dry.

! If you give too much: Talk to a doctor straight away. Take the medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

f If your child gets any of these serious side effects, stop giving the medicine. See a doctor at once:

•    Your child is sick and it contains blood or dark particles that look like coffee grounds

•    Pass blood in their stools or pass black tarry stools


•    Tiredness or severe exhaustion, changesln the blood which may cause unusual bruising or unexplained bleeding and an increase in the number of infections that they get

(e.g. sore throats, mouth ulcers, flu-like symptoms including fever)

•    Stomach problems including pain, indigestion or heartburn

•    Unexplained wheezing (asthma), worsening of existing asthma, difficulty in breathing, swelling of the face, tongue, neck or throat, fast heart rate, fainting, dizziness or collapse (severe allergic reactions)

•    Allergic skin reactions such as itchy, red, raised rash (which can sometimes be severe and include peeling, blistering and lesions of the skin)

•    Worsening of existing severe skin infections (you may notice a rash, blistering and discolouration of the skin, fever, drowsiness, diarrhoea and sickness), or worsening of other infections including chicken pox or shingles

•    Meningitis (e.g. stiff neck, fever, disorientation)

•    High blood pressure, heart failure (your child may be tired, have difficulty breathing or swollen legs)

•    A small increased risk of heart attack or stroke if they take large amounts for a long time

•    Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems)

•    Swellings or ulcers of the stomach

•    Kidney problems, which may lead to kidney failure (your child may pass more or less urine, have blood in the urine or cloudy urine, or feel breathless, very tired or weak, have no appetite, or have swollen ankles)

If your child gets any of the following side effects see your pharmacist or doctor:

•    Uncommon, feeling sick or rarely, being sick

•    Uncommon, headache

•    Rarely, diarrhoea, constipation and wind, and very rarely, worsening of colitis or

Crohn's disease

•    Frequency not known, swellings or ulcers of the mouth lining, fluid retention, which may cause swelling of the limbs

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C.

Keep this medicine in a safe place out of the sight anc( reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each 5 ml of oral suspension contains Ibuprofen 100 mg, which is the active ingredient. As well as the active ingredient, the suspension also contains purified water, maltitol liquid (E965), glycerol (E422), xanthan gum, sodium citrate, citric acid, sodium saccharin, sodium chloride, polysorbate 80, domiphen bromide, strawberry flavour.

The pack contains 30 ml, 50 ml, 100 ml or 150 ml of off white, strawberry-flavoured syrupy suspension. Not all pack sizes may be marketed.

Who makes this medicine

Manufactured for the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA by BCM Ltd Nottingham NG2 3AA Leaflet prepared November 2015 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA


ARTWORK ONLY

ARTWORK TEXT SIZE

Main Headings:

12pt

Sub Headings:

lOpt

Body Copy:

8pt


PACK 1VI0CK UP

Product Name: Ibuprofen 3 months plus 100 mg/5 ml Oral suspension strawberry flavour Product Licence No.: 00014/0859 Wording Ref: MHRA approved, V1, dated 28/05/15, (BTC184941 action C)

Status: Internally App roved Pack Details: PET bottle

Pack Size:

100 ml PET bottle

Version No.

Date Issued

Reason For Change

1

12/10/15

Type IB for the inclusion of the PRAC ibuprofen warnings for thrombotic effects

2

19/11/2015

NW6 issued for the inclusion of the PRAC ibuprofen warnings for thrombotic events and the inclusion of MHRA recommendations for children and adolescents.


Trident Reference No: BTCl 99787

Zen Ref:

TR1022877

Category:

Healthcare

Sub-Category:

Childrens 0TC

Brand:

Core

Pack Type:

Leaflet

Variant:

Ibuprofen 3 months Plus 100 mg/5 ml Oral

Suspension Strawberry Flavour 100 ml

Action:

D

Date:

23/11/15

Country:

UK

Component Code:

KHNS9

Item Code:

N/A

CAD Ref No:

148 mm x 270 mm

Printer:

N/A

Substrate:

White Paper

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By: N/A

(smallest bar)

Edgemark Position:

N/A

Pharmacode No/NE:

01010010(337)

Technical Et Non Printing Items Cutter ^ Guides


Colours

PANTONE 290 C

1


TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44(0) 1482 828100


KHNSB


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.


STUDIO USE ONLY Joshua James    vi.o


Information for the user


Ibuprofen 3 Months Plus 100 mg/5 ml Oral Suspension Strawberry Flavour

Read all of this leaflet carefully because it contains important information for you.



270 mm


This medicine is available without prescription to treat minor conditions. However, you still need to give it carefully to get the best results from it.

•    Keep this leaflet, you may need to read it again

•    Ask your pharmacist if you need more information or advice

•    The leaflet is written in terms of giving this medicine to your child, but if you are an adult who is intending to take this medicine yourself the information in this leaflet will apply to you as well

What this medicine is for

This medicine contains Ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which act to relieve pain, swelling (inflammation) and reduce fever. It can be used for the fast, effective relief of mild to moderate pain such as teething pain, toothache, earache, sore throat, headaches and minor aches and sprains. It can also be used to relieve the symptoms of colds and flu and to reduce fever, including fever after vaccination at 3 months of age.

Before you give this medicine

This medicine can be given to children from the age of 3 months. However, some children should not be given this medicine or you should seek the advice of their pharmacist or doctor first.

XDo not give:

   If your child is under 3 months old, or weighs less than 5 kg

•    If your child has a stomach ulcer, perforation or bleeding, or has had one twice or more in the past

•    If your child has had perforation or a bleeding stomach after taking a non-steroidal anti-inflammatory medicine (your child may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in their stools or passed black tarry stools)

   If your child is allergic to ibuprofen or any other ingredients in the product, aspirin or other non-steroidal anti-inflammatory medicines (your child has ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)

•    If your child has severe heart, kidney or liver failure

•    If your child is taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines (aspirin should not generally be given to children under 16, but doctors may occasionally prescribe it)

•    If your child has an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol liquid)

Other important information

Risk of heart attack or stroke:

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

f Talk to your pharmacist or doctor:

•    If your child has asthma, a history of asthma or other allergic disease

•    If your child has bowel problems, or Crohn's Disease

•    If your child has other kidney, heart or liver problems (see above)

•    If your child has connective tissue disorders such as SLE (Systemic Lupus Erythematosus)

•    If your child has chickenpox

•    If your child is on a low salt (sodium) diet (this medicine contains 11 mg of sodium per 5 ml spoonful)

•    If your child is dehydrated - they may get kidney problems

•    If your child has heart problems including heart failure, angina (chest pain), or has had aneart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke

XSPX7


(including 'mini-stroke' or transient ischaemic attack "TIA") - see 'Risk of heart attack or stroke' under “Other important information”

•    If your child has high blood pressure, diabetes, high cholesterol, has a family history of heart disease or stroke

If your child takes other medicines

Before you give this medicine, make sure that you tell your doctor or pharmacist about ANY other medicines you might be giving to the child at the same time. Ibuprofen may affect or be affected by some other medicines. For example:

•    Other pain killers (including NSAIDs)

•    Aspirin 75 mg (to prevent neart attacks or strokes) - the protection may be reduced when you take ibuprofen

•    Medicines to thin the blood (e.g. warfarin, ticlopidine)

•    Water tablets (diuretics)

•    Medicines to treat high blood pressure (e.g. ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan), medicines for neart problems

•    Corticosteroids (for pain and swelling)

•    Lithium (for bipolar disorder)

•    Methotrexate (for cancer, psoriasis or rheumatism)

•    Zidovudine (for HIV infection)

•    Quinolone antibiotics (for infection)

•    Medicines for depression (including selective serotonin re-uptake inhibitors)

•    Ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or rheumatism)

Some other medicines may also affect or be affected by the treatment of ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before your child uses this medicine with any other medicines, including herbal and homeopathic remedies.

Other information

Information about some of the ingredients:

Maltitol liquid may have a mild laxative effect. Each 5 ml spoonful contains 2.1 g maltitol. This provides 5 kcal per 5 ml spoonful. Information for adults intending to take this medicine

All the information in this leaflet applies to you as well.

If you are elderly you may be more likely to have some of the possible side effects listed lateri in the leaflet.

If you have had a stroke, have heart problems, you smoke, have high blood pressure, high cholesterol or diabetes talk to your pharmacist or doctor before you take this medicine (see 'Risk of heart attack or stroke' above).

Pregnancy: Do not take this medicine if you are in the last 3 months of pregnancy. Talk to your pharmacist or doctor if you are in the first 6 months of pregnancy.

Breastfeeding: Talk to your pharmacist or doctor before you take this medicine.

If you are a woman of childbearing age

taking this medicine, it may reduce your ability to become pregnant. This effect will be reversed on stopping the medicine.

Do not take this medicine if you have taken mifepristone (for termination of pregnancy) in the last 12 days.

/How to give this medicine

Check the cap seal is not broken before first use. If it is, do not give the medicine.

It is important to shake the bottle for at least 10 seconds before use.

Always use the syringe supplied with the pack. The syringe can be used to measure 2.5 ml or 5 ml by drawing the liquid to the correct mark on the syringe.


"GiveThis medicine to your chifcTto swallow.

Age

How much

How often

3 months up to 6 months weighing over 5 kg

2.5 ml

3 times in 24 hours

6 months up to 1 year

2.5 ml

3 to 4 times in 24 hours

1 year up to 4 years

5 ml

3 times in 24 hours

4 years up to 7 years

7.5 ml

3 times in 24 hours

7 years up to 10 years

10 ml

3 times in 24 hours

10 years up to 12 years

15 ml

3 times in 24 hours

Don't give more often than every 4 hours


Give the lowest amount for the shortest possible time to relieve the symptoms.

For infants aged 3 to 5 months, if symptoms worsen or do not go away within 24 hours talk to your doctor.

For a child of 6 months of age and over, if

this medicinal product is required for more than 3 days, or if symptoms worsen talk to your doctor.

For fever relief after vaccination at 3 months of age: Give 2.5ml. Give a second 2.5 ml after 6 hours, if you need to. Don't give any more medicine after second 2.5 ml. See a doctor if fever continues.

Do not give more than the amount recommended above.

Do not give to children under 3 months of age. Directions for using the syringe:

1.    Shake the bottle for at least 10 seconds before use.

2.    Push the syringe firmly into the plug (hole) in the neck of the bottle.

3.    To fill the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark (2.5 ml or 5 ml) on the syringe.

4.    Turn the bottle the right way up, and then gently twist the syringe to remove from the bottle plug.

5.    Place the end of the syringe into the child’s mouth, normally to the side of the mouth between the gums and cheek. Press the plunger down to slowly and gently release the medicine.

6.    If the table above advises you to give more than 5 ml of the medicine, repeat steps 2 to 5 to give your child the correct amount of medicine.

After use replace the cap on the top of the bottle tightly. Store all medicines out of the sight and reach of children.

Wash the syringe in warm water and allow to dry. ? If you give too much: Talk to a doctor straight away. Take the medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

f If your child gets any of these serious side effects, stop giving the medicine. See a doctor at once:

•    Your child is sick and it contains blood or dark particles that look like coffee grounds

•    Pass blood in their stools or pass black tarry stools

•    Tiredness or severe exhaustion, changes in the blood which may cause unusual bruising or unexplained bleeding and an increase in the number of infections that they get

(e.g. sore throats, mouth ulcers, flu-like symptoms including fever)

•    Stomach problems including pain, indigestion or heartburn

•    Unexplained wheezing (asthma), worsening of existing asthma, difficulty in breathing, swelling of the face, tongue, neck or throat, fest heart rate, fainting, dizziness or collapse (severe allergic reactions)


•    Allergic skfn reactions such asltchy, red, raised” rash (which can sometimes be severe and include peeling, blistering and lesions of the skin)

•    Worsening of existing severe skin infections (you may notice a rash, blistering and discolouration of the skin, fever, drowsiness, diarrhoea and sickness), or worsening of other infections including chicken pox or shingles

•    Meningitis (e.g. stiff neck, fever, disorientation)

•    High blood pressure, heart failure (your child may be tired, have difficulty breathing or swollen legs)

•    A small increased risk of heart attack or stroke if they take large amounts for a long time

•    Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems)

•    Swellings or ulcers of the stomach

•    Kidney problems, which may lead to kidney failure (your child may pass more or less urine, have blood in the urine or cloudy urine, or feel breathless, very tired or weak, have no appetite, or have swollen ankles)

If your child gets any of the following side effects see your pharmacist or doctor:

•    Uncommon, feeling sick or rarely, being sick

•    Uncommon, headache

•    Rarely, diarrhoea, constipation and wind, and very rarely, worsening of colitis or

Crohn's disease

•    Frequency not known, swellings or ulcers of the mouth lining, fluid retention, which may cause swelling of the limbs

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard. Use by the date on the end flap of the carton.

What is in this medicine

Each 5 ml of oral suspension contains Ibuprofen 100 mg, which is the active ingredient. As well as the active ingredient, the suspension also contains purified water, maltitol liquid (E965), glycerol (E422), xanthan gum, sodium citrate, citric acid, sodium saccharin, sodium chloride, polysorbate 80, domiphen bromide, strawberry flavour.

The pack contains 30, 50,100,150 or 200 ml of off white, strawberry-flavoured syrupy suspension. Not all pack sizes may be marketed.

Who makes this medicine

Manufactured for the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA by BCM Ltd Nottingham NG2 3AA Leaflet prepared November 2015 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA


ARTWORK ONLY

ARTWORK TEXT SIZE

Main Headings:

12pt

Sub Headings:

lOpt

Body Copy:

8pt


PACK MOCK LIP

Product Name: Ibuprofen 3 months plus 100 mg/5 ml Oral suspension strawberry flavour Product Licence No.: 00014/0859 Wording Ref: MHRA approved, VI, dated 28/05/15, (BTC183519 action B)

Status: Internally Approved Pack Details: PET bottle

Pack Size:

200ml

Version No.

Date Issued

Reason For Change

1

01/10/15

Type IB for the inclusion of the PRAC ibuprofen warnings for thrombotic effects.

2

19/11/2015

NWG issued for the inclusion of the PRAC ibuprofen warnings for thrombotic events and the inclusion of MHRA recommendations for children and adolescents.


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Trident Reference No:

BTC199781

Zen Ref:

TR1022831

Category:

Healthcare

Sub-Category:

Childrens 0TC

Brand:

Core

Pack Type:

Leaflet

Variant:

Ibuprofen 3 Months Plus 100 mg/5 ml Oral Suspension Strawberry Flavour 200ml/P

Action:

c

Date:

23/11/15

Country:

UK

Component Code:

XSPX7

Item Code:

77-86-492

CAD Ref No:

148 mm x 270 mm

Printer:

N/A

Substrate:

White Paper

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By: (smallest bar)

N/A

Edgemark Position:

N/A

Pharmacode No/NE:

0101101(172)

Technical Et Non Printing Items Cutter ^ Guides


Colours

PAMONE280C

=


TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.


STUDIO USE ONLY Joshua James    vi.o


'ISpBlLUBl^d jnoA >|SB eowpe guolu peeu noA n


/How to give this medicine

Check the cap seal is not broken before first use. If it is, do not give the medicine.

It is important to shake the bottle for at least 10 seconds before use.

Always use the syringe supplied with the pack. The syringe can be used to measure 2.5 ml or 5 ml by drawing the liquid to the correct mark on the syringe.

Give this medicine to your child to swallow.


Directions for using the syringe: “


1.



3 MONTHS PLUS

100mg/5ml Oral Suspension

STRAWBERRY FLAVOUR


Ink & Yarn Free


Age

How much

How often

3 months up to 6 months weighing over 5 kg

2.5 ml

3 times in 24 hours

6 months up to 1 year

2.5 ml

3 to 4 times in 24 hours

1 year up to 4years

5 ml

3 times in 24 hours

4 years up to 7years

7.5 ml

3 times in 24 hours

7 years up to 10 years

10 ml

3 times in 24 hours

10 years up to 12 years

15 ml

3 times in 24 hours

| Don't give more often than every 4 hours |


Give the lowest amount for the shortest possible time to relieve the symptoms.

For infants aged 3 to 5 months, if

symptoms worsen or do not go away within 24 hours talk to your doctor.

For a child of 6 months of age and over,

if this medicinal product is required for more than 3 days, or if symptoms worsen talk to your doctor.

Other uses

For fever relief after vaccination at 3 months of age: Give 2.5ml. Give a second 2.5 ml after 6 hours, if you need to. Don't give any more medicine after second 2.5 ml.

See a doctor if fever continues.

Do not give to children under 3 months of age.

| Warning: Do not exceed the stated dose |


Shake the bottle for at least 10 seconds before use.

Push the syringe firmly into the plug (hole) in the neck of the bottle.

To till the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark (2.5 ml or 5 ml) on the syringe.

Turn the bottle the right way up, and then gently twist the syringe to remove from the bottle plug.

Place the end of the syringe into the child’s mouth, normally to the side of the mouth between the gums and cheek. Press the plunger down to slowly and gently release the medicine.

If the table advises you to give more than 5 ml of the medicine, repeat steps 2 to 5 to give your child the correct amount of medicine.

After use replace the cap on the top of the bottle tightly. Store all medicines out of the sight and reach of children.

Wash the syringe in warm water and allow to dry.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

Each 5 ml of oral suspension contains Ibuprofen 100 mg.

Also contains: maltitol liquid (E965), sodium citrate, sodium saccharin, sodium chloride. See enclosed leaflet for further information.


6.


100 mie

PL 00014/0859    0

The Boots Company PLC Nottingham NG23AA



3 MONTHS PLUS

100mg/5ml Oral Suspension


STRAWBERRY FLAVOUR


FAST EFFECTIVE RELIEF FROM PAIN & FEVER


V Relief of cold and flu symptoms and fever after vaccination


' Read andTreep leafleFferlull" instructions.


What this medicine is for

For the fast, effective relief of mild to moderate pain such as teething pain, toothache, earache, sore throat, headaches and minor aches and sprains. It can also be used to relieve the symptoms of colds and flu and to reduce fever, including fever after vaccination at 3 months of age.

Before you give this medicine


XDo not give:

If your child is under 3 months old, or



weighs less than 5 kg

•    If your child has a stomach ulcer, perforation or bleeding, or has had one

twice or more in the past

•    If your child is allergic to ibuprofen or any other ingredients in the product, aspirin or other non-steroidal anti-inflammatory medicines

•    If your child has severe heart; kidney or liver failure

•    If your child is taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines

f Talk to your pharmacist or doctor:

•    If your child has, or has had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

•    If your child has connective tissue disorders such as SLE (Systemic Lupus Erythematosus^

•    If your child has chickenpox If you are an adult and:

-    You are elderly

-    You smoke

-    You are breastfeeding

-    You are pregnant, or trying to become pregnant

If your child is on a low salt (sodium) diet (this medicine contains 11 mg of sodium per 5 ml spoonfu}



Lot: and Use By: overprinted by the factory


ARTWORK ONLY

ARTWORK TEXT SIZE

Main Headings:

11 pt

Sub Headings:

9pt

Body Copy:

?Pt


PACK MOCK UP

Product Name: Ibuprofen 3 months plus 100 mg/5 ml Oral suspension strawberry flavour

Product Licence No.: 00014/0859

Wording Ref: MHRA approved dated 01/10/2013 (BTC122966 C) Status: Internally approved Pack Details: PET bottle

Pack Size:

100 ml

Version No.

Date Issued

Reason For Change

1

20/11/2015

Inclusion of MHRA recommendations for children and adolescents (submitted with the NWG issued for the inclusion of the PRAC ibuprofen warnings)


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Trident Reference No: BTC199788

Zen Ref:

TR1049493

Category:

Healthcare

Sub-Category:

Childrens 0TC

Brand:

Core

Pack Type:

Carton

Variant:

Ibuprofen 3 months Plus 100 mg/5 ml Oral Suspension Strawberry Flavour 100 ml

Action:

A

Date:

26/11/15

Country:

UK

Component Code:

KSTL2

Item Code:

N/A

CAD Ref No:

49 mm x 49 mm x 125 mm

Printer:

N/A

Substrate:

White Carton Board

Barcode Type:

EAN 13

Barcode Number:

0000000000000

Magnification:

100%

Barcode Truncated By: (smallest bar)

0.0 mm

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical ft Non Printing Items Cutter | Guides


Colours


E3

TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.


STUDIO USE ONLY Michael Woodhead    v1.0


253 mm


<D

<D

U


a

u

aS

>


US


a


/How to give this medicine

Check the cap seal is not broken before first use. If it is, do not give the medicine.

It is important to shake the bottle for at least 10 seconds before use.

Always use the syringe supplied with the pack. The syringe can be used to measure 2.5 ml or 5 ml by drawing the liquid to the correct mark on the syringe.


3 montiis up ( to (^months wemhing over 5 kg

How much

How often

[2.5 ml • • •• • •

3 times in 24 (jours

6 rribriths up ' to 1 yftr

'2.5fnl *

S to 4 times in 24 hours

1 yfcr ujfto * 4 yea* 1

■rfWP

3 times in 24 hours

4yRif jpto* 7y«rs

'7%Wil *

• •

3 times fo 24 hours

7yR*d|5to

10 years* <

10 ml

5 times in 24 hours

10^ar^lpto 12 years

-fcffil ' • ••

S times in 24 hours

Dofft^jive m#r#often than every 4 hours


Giv9the lowest amoum foi the shortest possible time to rSlCTe thff^hnptoms.

For infants ajffe*3 to 5*ionths, if symptoms wo*en Ado lot gc away within 24 l^urs talk to ^gpr doctor.

For a '■h’M of S mqpths of age and over, if this medicinaTproauct is required for more


if this medicinahoroduct is reguii thaiftftavs, orn symptoi^Rrorsen talk to your dftflr. •    •    •


Other uses • •

For .eve, relief after vaccfflation at 3 months of agf Give 2.5ml. Give a second 2.5 tpl aflgr 6 hours, if yo*need to. Don't give any morejngpi^ine after second 2.5 ml.


See a doctor inCTEiTontll Do "t*ive to childrm under 3 | Warning: Do not exceed the stated dose |



'ISpBlLUBl^d jnoA >|SB eowpe euoai peeu noA n


3 MONTHS PLUS

100mg/5ml Oral Suspension


Directions for using the syringe: “

' Read andTreep leafleFForTuTI" instructions.


3 MONTHS PLUS

100mg/5ml Oral Suspension


STRAWBERRY FLAVOUR


FAST EFFECTIVE RELIEF FROM PAIN & FEVER


V Relief of cold and flu symptoms and fever after vaccination


PL 1001*0859 ••IB The Boots Company PLC Nottingham NG23AA



v


weighs less than 5 kg

•    If your child has a stomach ulcer, perforation or bleeding, or has had one

twice or more in the past

•    If your child is allergic to ibuprofen or any other ingredients in the product, aspirin or other non-steroidal anti-inflammatory medicines

•    If your child has severe heart; kidney or liver failure

•    If your child is taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines

f Talk to your pharmacist or doctor:

•    If your child has, or has had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

•    If your child has connective tissue disorders such as SLE (Systemic Lupus Erythematosus^

•    If your child has chickenpox If you are an adult and:

-    You are elderly

-    You smoke

-    You are breastfeeding

-    You are pregnant, or trying to become pregnant

If your child is on a low salt (sodium) diet (this medicine contains 11 mg of sodium per 5 ml spoonfu}


Lot: and Use By: overprinted by the factor


1.


Shake the bottle for at least 10 seconds before use.

Push the syrirae firmly into the plug (hole) in the neck^f Ji^Dottle.

To till the synnge™urn the bottle upside down. Whilst holing the syringe in place, gently pull Me pLiger down drawing the medicine to tt^ correct mark (2.5 ml or 5 ml) on tha^yriiyie.

Turn the bottle the right way up, and then


twist Jhe ^inge to remove from


beetle

Plagp the end of the syringe into the qtiild'*nou|ki, normally to the side of the mouth between the gums and cheek, fless the plunger down to slowly and geifly relealb%“medicine.

I" the table advises you to give more than 5 n ' c ’ the it licine, repeat steps 2 to 5 to cm/e your child the correct amount of jeHcjie.

After use replace the cap on the top of the bottle ^jhtly. Sftil At medicines out of the sigtland reaclof children.

Wall the syringeli warm water and allow to dry* • •    • • •


6.


.this medicine

f5°C.


Do noretOre al Keep alWnedicMes out of the sight and reafh of jhilcen.

Usgpty the date on the end flap of the carton,

ActiVMncft€dient

Each 5 ml of cM%JS|sension contains Ibuprofen 100 mff

Also contains: maltitol liquid (E965), sodium citrMeasMiiunaBaccharin, sodium chloride. See enclosed le^t for further information.

• •••


• •



What this medicine is for

For the fast, effective relief of mild to moderate pain such as teething pain, toothache, earache, sore throat, headaches and minor aches and sprains. It can also be used to relieve the symptoms of colds and flu and to reduce fever, including fever after vaccination at 3 months of age.

Before you give this medicine


XDo not give:

If your child is under 3 months old, or


• •

• •

• •

• ••

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• • •


Boots lbuprofen “3 months plus TglTlOO mg/“r5 ml oral suspension strawberry flavour


ARTWORK ONLY

ARTWORK TEXT SIZE

Trident Reference No: BTC199788

Zen Ref:

TR1049493

Category:

Healthcare

Sub-Category:

Childrens 0TC

Brand:

Core

Pack Type:

Carton

Variant:

Ibuprofen 3 months Plus 100 mg/5 ml Oral

Suspension Strawberry Flavour 100 ml

Action:

A

Date:

26/11/15

Country:

UK

Component Code:

KSTL2

Item Code:

N/A

CAD Ref No:

49 mm x 49 mm x 125 mm

Printer:

N/A

Substrate:

White Carton Board

Barcode Type:    EAN 13

Barcode Number:    0000000000000

Magnification:    100%

Barcode Truncated By:    0.0 mm

(smallest bar)

Edgemark Position:    N/A

Pharmacode No/NE:    N/A


Main Headings:

11 pt

Sub Headings:

9pt

Body Copy:

?Pt


PACK MOCK OP

Product Name: lbuprofen 3 months plus 100 mg/5 ml Oral suspension strawberry flavour

Product Licence No.: 00014/0859

Wording Ref: MHRA approved dated 01/10/2013 (BTC122966 C) Status: Internally approved Pack Details: PET bottle

Pack Size:

100 ml

Version No.

Date Issued

Reason For Change

1

20/11/2015

Inclusion of MHRA recommendations for children and adolescents (submitted with the NWG issued for the inclusion of the PRAC ibuprofen warnings)


Technical Et Non Printing Items Cutter | Guides

Colours


E3

TRIDENT

Connaught Bouse, Connaught Road, Kingswood Business Park, Bull, HU7 3AP, England. T: +44 (0) 1482 828100


TECHM1CAL 1MEO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.


STUDIO USE ONLY Michael Woodhead    vt.O



Ink & Yarn Free






• • •

• •

• •

• •

1 • •

0

• •

1 • •

• • •

• •

• • •

0

1

1

• ••

• • •

• •

1 00

• ••

• • •

1 • *

• • •

000

• ••

1

• •

1

• •

• •

1 • ••

• • •

• • •

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• •

• •

1

• •

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1 * *

00

• • •

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1

0 0 0

0

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• ••

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Lot: and Use By: overprinted by the factory


• •

• •

• •

• ••

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• •

• • •


Boots lbuprofen “3 months plus TglTlOO mg/“r5 ml oral suspension strawberry flavour


ARTWORK ONLY

ARTWORK TEXT SIZE

Trident Reference No: BTC199788

Zen Ref:

TR1049493

Category:

Healthcare

Sub-Category:

Childrens 0TC

Brand:

Core

Pack Type:

Carton

Variant:

Ibuprofen 3 months Plus 100 mg/5 ml Oral

Suspension Strawberry Flavour 100 ml

Action:

A

Date:

26/11/15

Country:

UK

Component Code:

KSTL2

Item Code:

N/A

CAD Ref No:

49 mm x 49 mm x 125 mm

Printer:

N/A

Substrate:

White Carton Board

Barcode Type:    EAN 13

Barcode Number:    0000000000000

Magnification:    100%

Barcode Truncated By:    0.0 mm

(smallest bar)

Edgemark Position:    N/A

Pharmacode No/NE:    N/A


Main Headings:

11 pt

Sub Headings:

9pt

Body Copy:

?Pt


PACK MOCK OP

Product Name: lbuprofen 3 months plus 100 mg/5 ml Oral suspension strawberry flavour

Product Licence No.: 00014/0859

Wording Ref: MHRA approved dated 01/10/2013 (BTC122966 C) Status: Internally approved Pack Details: PET bottle

Pack Size:

100 ml

Version No.

Date Issued

Reason For Change

1

20/11/2015

Inclusion of MHRA recommendations for children and adolescents (submitted with the NWG issued for the inclusion of the PRAC ibuprofen warnings)


Technical Et Non Printing Items Cutter | Guides

Colours


E3

TRIDENT

Connaught Bouse, Connaught Road, Kingswood Business Park, Bull, HU7 3AP, England. T: +44 (0) 1482 828100


TECHM1CAL 1MEO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.


STUDIO USE ONLY Michael Woodhead    vt.O


'ISpBlLUBl^d jnoA >|SB eowpe guolu peeu noA n


/How to give this medicine

Check the cap seal is not broken before first use. If it is, do not give the medicine.

It is important to shake the bottle for at least 10 seconds before use.

Always use the syringe supplied with the pack. The syringe can be used to measure 2.5 ml or 5 ml by drawing the liquid to the correct mark on the syringe.

Give this medicine to your child to swallow.



3 MONTHS PLUS

100mg/5ml Oral Suspension

STRAWBERRY FLAVOUR


Ink & Yarn Free


Age

How much

How often

3 months up to 6 months weighing over 5 kg

2.5 ml

3 times in 24 hours

6 months up to 1 year

2.5 ml

3 to 4 times in 24 hours

1 year up to 4years

5 ml

3 times in 24 hours

4 years up to 7years

7.5 ml

3 times in 24 hours

7 years up to 10 years

10 ml

3 times in 24 hours

10 years up to 12 years

15 ml

3 times in 24 hours

| Don't give more often than every 4 hours |


Give the lowest amount for the shortest possible time to relieve the symptoms.

For infants aged 3 to 5 months, if

symptoms worsen or do not go away within 24 hours talk to your doctor.

For a child of 6 months of age and over,

if this medicinal product is required for more than 3 days, or if symptoms worsen talk to your doctor.

Other uses

For fever relief after vaccination at 3 months of age: Give 2.5ml. Give a second 2.5 ml after 6 hours, if you need to. Don't give any more medicine after second 2.5 ml.

See a doctor if fever continues.

Do not give to children under 3 months of age.

| Warning: Do not exceed the stated dose |


“ "Directions for using the syringe:

1.    Shake the bottle for at least 10 seconds before use.

2.    Push the syringe firmly into the plug (hole) in the neck of the bottle.

3.    To till the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark (2.5 ml or

5 ml) on the syringe.

4.    Turn the bottle the right way up, and then gently twist the syringe to remove from the bottle plug.

5.    Place the end of the syringe into the child’s mouth, normally to the side of the mouth between the gums and cheek. Press the plunger down to slowly and gently release the medicine.

6.    If the table advises you to give more than 5 ml of the medicine, repeat steps 2 to 5 to give your child the correct amount of medicine.

After use replace the cap on the top of the bottle tightly. Store all medicines out of the sight and reach of children.

Wash the syringe in warm water and allow to dry.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

Each 5 ml of oral suspension contains Ibuprofen 100 mg.

Also contains: maltitol liquid (E965), sodium citrate, sodium saccharin, sodium chloride. See enclosed leaflet for further information.



3 MONTHS PLUS

100mg/5ml Oral Suspension

STRAWBERRY FLAVOUR


FAST EFFECTIVE RELIEF FROM PAIN & FEVER

</ Relief of cold and flu symptoms and fever after vaccination


100 mie

PL 00014/0859    0

The Boots Company PLC Nottingham NG23AA



' Read and "keep leafleFferluTI instructions.

What this medicine is for

For the fast, effective relief of mild to moderate pain such as teething pain, toothache, earache, sore throat, headaches and minor aches and sprains. It can also be used to relieve the symptoms of colds and flu and to reduce fever, including fever after vaccination at 3 months of age.

Before you give this medicine XDo not give:

•    If your child is under 3 months old, or

weighs less than 5 kg

•    If your child has a stomach ulcer, perforation or bleeding, or has had one

twice or more in the past

•    If your child is allergic to ibuprofen or any other ingredients in the product, aspirin or other non-steroidal anti-inflammatory medicines

•    If your child has severe heart; kidney or liver failure

•    If your child is taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines

f Talk to your pharmacist or doctor:

•    If your child has, or has had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

•    If your child has connective tissue disorders such as SLE (Systemic Lupus Erythematosus^

•    If your child has chickenpox

•    If you are an adult and:

-    You are elderly

-    You smoke

-    You are breastfeeding

-    You are pregnant, or trying to become pregnant

•    If your child is on a low salt (sodium) diet (this medicine contains 11 mg of sodium per 5 ml spoonfu}


“V



0 0I



ARTWORK ONLY

ARTWORK TEXT SIZE

Main Headings:

11 pt

Sub Headings:

9pt

Body Copy:

?Pt


PACK MOCK OP

Product Name: Ibuprofen 3 months plus 100 mg/5 ml Oral suspension strawberry flavour

Product Licence No.: 00014/0859

Wording Ref: MHRA approved dated 01/10/2013 (BTC122966 C) Status: Internally approved Pack Details: PET bottle

Pack Size:

100 ml

Version No.

Date Issued

Reason For Change

1

20/11/2015

Inclusion of MHRA recommendations for children and adolescents (submitted with the NWG issued for the inclusion of the PRAC ibuprofen warnings)


Category:

Healthcare

Sub-Category:

Childrens 0TC

Brand:

Core

Pack Type:

Carton

Variant:

Ibuprofen 3 months Plus 100 mg/5 ml Oral Suspension Strawberry Flavour 100 ml

Action:

A

Date:

26/11/15

Country:

UK

Component Code:

KSTL2

Item Code:

N/A

CAD Ref No: Printer:

49 mm x 49 mm x 125 mm

Substrate:

White Carton Board

Barcode Type:

EAN 13

Barcode Number:

0000000000000

Magnification:

100%

Barcode Truncated By: (smallest bar)

0.0 mm

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical ft Non Printing Items Cutter | Guides


Colours


TECHNICAL INFO: PRINTER PLEASE NOTE

STUDIO USE ONLY    v1.0


Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.





■}speiwEi|cl jnoA>(SB sowpB aioiu p88u noA II


3 MONTHS PLUS 100mg/5ml Oral Suspension

STRAWBERRY FLAVOUR

296 mm


/How to give this medicine

Check the cap seal is not broken before first use. If it is, do not give the medicine.

It is important to shake the bottle for at least 10 seconds before use.

Always use the syringe supplied with the pack. The syringe can be used to measure 2.5 ml or 5 ml by drawing the liquid to the correct mark on the syringe.


Give this medicine to your child to swallow.

Age

How much

How often

3 months up to 6 months weighing over 5 kg

2.5 ml

3 times in 24 hours

6 months up to 1 year

2.5 ml

3 to 4 times in 24 hours

1 year up to 4 years

5 ml

3 times in 24 hours

4 years up to 7 years

7.5 ml

3 times in 24 hours

7 years up to 10 years

10 ml

3 times in 24 hours

10 years up to 12 years

15 ml

3 times in 24 hours

| Don't give more often than every 4 hours |

Give the lowest amount for the shortest possible time to relieve the symptoms.


For infants aged 3 to 5 months, if

symptoms do not go away, talk to your doctor within 24 hours.

For a child of 6 months of age and over, if

this medicinal product is required for more than 3 days, or if symptoms worsen talk to your doctor.

Other uses

For fever relief after vaccination at 3 months of age: Give 2.5ml. Give a second 2.5 ml after 6 hours, if you need to. Don't give any more medicine after second 2.5 ml.

See a doctor if fever continues.

Do not give to children under 3 months of age.

I Warning: Do not exceed the stated dose I


Directions for using die syringe:

1.    Shake the bottle for at least 10 seconds before use.

2.    Push the syringe firmly into the plug (hole) in the neck of the bottle.

3.    To fill the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark (2.5 ml or

5 ml) on the syringe.

4.    Turn the bottle the right way up, and then gently twist the syringe to remove from the bottle plug.

5.    Place the end of the syringe into the child’s mouth, normally to the side of the mouth between the gums and cheek. Press the plunger down to slowly and gently release the medicine.

6.    If the table advises you to give more than 5 ml of the medicine, repeat steps 2 to 5 to give your child the correct amount of medicine.

After use replace the cap on the top of the bottle tightly. Store all medicines out of the sight and reach of children.

Wash the syringe in warm water and allow to dry.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

Each 5 ml of oral suspension contains Ibuprofen 100 mg.

Also contains: maltitol liquid (E965), sodium citrate, sodium saccharin, sodium chloride. See enclosed leaflet for further information.

200 ml e

PL 00014/0859 E The Boots Company PLC . Nottingham J\[G2 3AA___

3 MONTHS PLUS

100mg/5ml Oral Suspension

STRAWBERRY FLAVOUR

FAST EFFECTIVE RELIEF FROM PAIN & FEVER

V Relief of cold and flu symptoms and fever after vaccination

77-86-492

7



5 045097 786494 >



I    1 Reatfand keep leaflet for full | 1 | instructions.

' I '

II    What this medicine is for

| . | For the fast, effective relief of mild to i i moderate pain such as teething pain,

1 I 1 toothache, earache, sore throat, headaches ! | | and minor aches and sprains. It can also be ' used to relieve the symptoms of colds and 1 | flu and to reduce fever, including fever after

I i vaccination at 3 months of age.

1

| I

! Before you give this ,; medicine

i XDo not give:

I | • If your child is under 3 months old, or

i weighs less than 5 kg i • If your child has a stomach ulcer,

I i perforation or bleeding, or has had one

■ ] twice or more in the past i • If your child is allergic to ibuprofen or any I | other ingredients in the product, aspirin or I i other non-steroidal anti-inflammatory . | medicines

i • If your child has severe heart, kidney or I 1 liver failure

I i • If your child is taking aspirin with a daily | dose above 75 mg, or other non-steroidal 1 I anti-inflammatory medicines

, f Talk to your pharmacist or 1 ! doctor:

I 1 • If your child has, or has had asthma,

! | | diabetes, high cholesterol, high blood i pressure, a stroke, heart, liver, kidney or 1 ] bowel problems

i l i • If your child has connective tissue disorders j , ] such as SLE (Systemic Lupus Erythematosus) i l•lfyourchildhaschickenpox ! ' i»lfyou are an adult and:

I i - You are elderly , ] - You smoke j i - You are breastfeeding s I 1 - You are pregnant, or trying to become J I | pregnant

3    1 • If your child is on a low salt (sodium) diet

1 | (this medicine contains 11 mg of sodium per I ' 5 ml spoonfljl)


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


ARTWORK TEXT SIZE

ARTWORK ONLY

Trident Reference No: BTCl 99785

Zen Ref:

TR1049482

Category:

Healthcare

Sub-Category:

Childrens 0TC

Brand:

Core

Pack Type:

Carton

Variant:

Ibuprofen 3 Months Plus 100 mg/5 ml Oral Suspension Strawberry Flavour 200ml/P

Action:

B

Date:

02/12/15

Country:

UK

Component Code:

KXWE1

Item Code:

77-86-492

CAD Ref No:

58 mm x 58 mm x 150 mm

Printer:

N/A

Substrate:

White Carton Board

Barcode Type:

EAN 13

Barcode Number:

504509778G494

Magnification:

100%

Barcode Truncated By: 0.0 mm

(smallest bar) Edgemark Position:

3

Pharmacode No/NE:

1011001000(1735)

Technical ft Non Printing Items Cutter J Guides




Lot: and Use By: overprinted by the factory


Main Headings:

12pt

Sub Headings:

lOpt

Body Copy:

8pt


PACK MOCK UP

Product Name:

Product Licence No.: Wording Ref:

Status:

Pack Details:

Ibuprofen 3 months plus 100 mg/5 ml Oral suspension strawberry flavour

00014/0859

MHRA approved dated 03/10/2013 (BTC124149 C} Internally approved PET bottle

Pack Size:

200 ml

Version No.

Date Issued

Reason For Change

1

20/11/2015

Inclusion of MHRA recommendations for children and adolescents (submitted with the NWG issued for the PRAC Ibuprofen warnings)


Colours


TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.


STUDIO USE ONLY Joshua James    vi.o

Sm»Art check results: G=1; 0=0; R=0; - JJ - 02/12/15 09:38:14



■}speiwEi|d jnoA>(se eowpe aioiu peeu noA j|


3 MONTHS PLUS 100mg/5ml Oral Suspension

STRAWBERRY FLAVOUR

/How to give this medicine

Check the cap seal is not broken before first use. If it is, do not give the medicine.

It is important to shake the bottle for at least 10 seconds before use.

Always use the syringe supplied with the pack. The syringe can be used to measure 2.5 ml or 5 ml by drawing the liquid to the correct mark on the syringe.


Give this medicine to your child to swallow.

Age

How much

How often

3 months up to 6 months weighing over 5 kg

2.5 ml

3 times in 24 hours

6 rfWtths up tofye#

2.5 ml

3 to 4 times in 24 hours

It

i— ■'d-

i5/m.

3 times in 24 hours

4 up ta 7yeqjs

7$m{ #

3 times in 24 hours

7 \ears*p te « 10yq§rs #

10 ml

3 times in 24 hours

10^dlrf up*A 12eears

ml®

• • •

3 times in 24 hours

| Don't give more often tMBn every 4 hours |

Givp thr lowent nmount for the shortest possible time t<^reliev^t|jp^ymptoms.


ForMants aged 3 to 5 months, if

synjptoms df opt go %ygy, talk to your doctoewithin 2it»ur» •

For a child ef • monttis of age and over, if

this medicinsfprc*uct% required for more tha»3 days, onaf symptoms worsen talk to your atoator. •    •

Otfifjr jus#    • •

For fiver relief after vaccination at 3 months of age: Givet.iml. Give a second 2.5fnl dter 6 hours, if ycfl need to. Don't give any move medicine after second 2.5 ml. Se^i dflfctoflf fever cfntinues.

Do jo^give t9 ffi^lrerftifftjr 3 months of age.

I Warning: Do not exceed the stated dose I


296 mm



Directions for using the syringe:

1.    Shake the bottle for at least 10 seconds before use.

2.    Push the syringe firmly into the plug (hole) in the neck of the bottle.

3.    To fill the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark (2.5 ml or

5 ml) on the syringe.

4.    Turn the bottle the right way up, and then gently twist the syringe to remove from the bottle plfg.

5.    Place the%ifiSfthe syringe into the child’s mouth formally to the side of the mouth b^tvedPi the gums and cheek.

Press the ptonger down to slowly and gently rel«se#ie medicine.

6.    lit*?' table ad\*es you to give more than I ml ef the sseslicine, repeat steps 2 to 5 toflive your child the correct amount of giedigine*

Aftar use replace the cap on the top of the bottleatightlyaQlon all medicines out of the sig* and re^ph of children.

Waslftlft s^Hfe in warm water and allow to diyee • •

Howto sMife this medicine

DoTiot storeabove 25°C.

Ke^a" mrd'nres out of the sight and re^h of chik^en.

Use I* #ie (fat* «i the end flap of the carton.

• •

Active ingredient

Eaflh 5 ml of oral suspension contains lbuprfll#i Itflftig.

Also contain? JiStitol liquid (E965), sodium citrate, sodium saccharin, sodium chloride. Se^^iiJisejJ leaflet for further information.

• •••

2(5(JTnl|e#

PL«0OW/O85S *0 The Boots Company PLC

. Nottingham J\[G2 3AA_____________

3 MONTHS PLUS

100mg/5ml Oral Suspension

STRAWBERRY FLAVOUR

FAST EFFECTIVE RELIEF FROM PAIN & FEVER

V Relief of cold and flu symptoms and fever after vaccination

77-86-492



5 045097 786494 >


BRAILLE CONVERSION - English



I    1 Reatfand keep leaflet for full | 1 | instructions.

' I '

II    What this medicine is for

| . | For the fast, effective relief of mild to i i moderate pain such as teething pain,

1 I 1 toothache, earache, sore throat, headaches ! | | and minor aches and sprains. It can also be ' used to relieve the symptoms of colds and 1 | flu and to reduce fever, including fever after I i vaccination at 3 months of age.

I

| I

! Before you give this ,; medicine

i XDo not give:

I | • If your child is under 3 months old, or

i weighs less than 5 kg i • If your child has a stomach ulcer,

I i perforation or bleeding, or has had one

■ ] twice or more in the past i • If your child is allergic to ibuprofen or any I | other ingredients in the product, aspirin or I i other non-steroidal anti-inflammatory . | medicines

i • If your child has severe heart, kidney or I 1 liver failure

' | i* If your child is taking aspirin with a daily | . | dose above 75 mg, or other non-steroidal I 1 I anti-inflammatory medicines

, f Talk to your pharmacist or I 1 ! doctor:

I I 1 • If your child has, or has had asthma,

S I | diabetes, high cholesterol, high blood J i pressure, a stroke, heart, liver, kidney or ! 1 ] bowel problems

< I i • If your child has connective tissue disorders ! , ] such as SLE (Systemic Lupus Erythematosus) i l•lfyourchildhaschickenpox ! ' i»lfyou are an adult and:

I i - You are elderly : , ] - You smoke 5 i - You are breastfeeding 3 I 1 - You are pregnant, or trying to become s I I pregnant

j 1 • If your child is on a low salt (sodium) diet I 1 | (this medicine contains 11 mg of sodium per I I ' 5 ml spoonfljl)


• •

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Boots Ibuprofen “3 months plus Ns^r100 mg/“cr5 ml oral suspension strawberry flavour


ARTWORK ONLY

TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Trident Reference No:

BTC199785

Zen Ref:

TR1049482

Category:

Healthcare

Sub-Category:

Childrens 0TC

Brand:

Core

Pack Type:

Carton

Variant:

Ibuprofen 3 Months Plus 100 mg/5 ml Oral

Suspension Strawberry Flavour 200ml/P

Action:

B

Date:

02/12/15

Country:

UK

Component Code:

KXWE1

Item Code:

77-86-492

CAD Ref No:

58 mm x 58 mm x 150 mm

Printer:

N/A

Substrate:

White Carton Board

Barcode Type:    EAN 13

Barcode Number:    504509778G494

Magnification:    100%

Barcode Truncated By: 0.0 mm (smallest bar)

Edgemark Position:    3

Pharmacode No/NE: 1011001000(1735)


ARTWORK TEXT SIZE

r\




Lot: and Use By: overprinted by the factory


Main Headings:

12pt

Sub Headings:

lOpt

Body Copy:

8pt


PACK MOCK UP

Product Name:

Product Licence No.: Wording Ref:

Status:

Pack Details:

Ibuprofen 3 months plus 100 mg/5 ml Oral suspension strawberry flavour

00014/0859

MHRA approved dated 03/10/2013 (BTC124149 C) Internally approved PET bottle

Pack Size:

200 ml

Version No.

Date Issued

Reason For Change

1

20/11/2015

Inclusion of MHRA recommendations for children and adolescents (submitted with the NWG issued for the PRAC Ibuprofen warnings)

Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.

STUDIO USE ONLY Joshua James    vi.o

Sm»Art check results: G=1; 0=0; R=0; - JJ - 02/12/15 09:38:14


Technical Ft Non Printing Items Cutter ^ Guides

Colours


E3

TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44(0) 1482 828100


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.


296 mm



BRAILLE CONVERSION - English

• •

• •

• •

• ••

• •

• •