Medine.co.uk

Infant Sugar Free Gripe Mixture

Document: label-leaflet MAH BRAND_PL 00014-5236R change

233 mm

/How to give this medicine

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

Use the measuring spoon provided (the big end of the spoon measures 5 ml).

Give this medicine to your baby to swallow. Do not add this medicine to feeds or bottles.


Ink & Varnish Free


Age

How much

How often to give

1 to 5 months

5 ml

Before or after each feed, if you need to. Don’t give more than 6 times in 24 hours.

6 to 11 months

10 ml

Before or after each feed, if you need to. Don’t give more than 6 times in 24 hours.


Do not give to babies under 1 month.

Do not give to babies of 1 year and over.

Do not give more than the amount recommended above.

If symptoms do not go away talk to your pharmacist or doctor.

? If you give too much: Talk to a doctor straight away - your baby may be drowsy, irritable, have a fever or breathing problems.

Possible side effects

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

? If your child gets any of these serious side effects, stop giving the liquid.

See a doctor at once:

•    Difficulty breathing, swelling of the face, neck, tongue or throat (severe allergic reaction)

! If too much is given, or too often, your baby may get:

•    Changes in the chemistiy of the blood - your baby may be drowsy, irritable, or have breathing problems - talk to a doctor straight away if you notice this


PHARMACEUTICALS


GRIPE MixturB

1 MONTH PLUS

Sodium Bicarbonate


y Relief of wind and griping pain >/ For use before or after feeds


_1_50mie


23-18-415


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

•    Other allergic reactions (e.g. skin rash)

•    Stomach cramps, being sick, burping, wind

•    Your child may appear generally unwell (e.g. lacking in energy, feverish)

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 on this carton. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.ukA/ellowcard. By reporting side effects you can help provide more information on the safely of this medicine.

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.

Throw away any Gripe Mixture remaining 12 weeks after opening.

Active ingredient

Each 5 ml of liquid contains Sodium Bicarbonate 50 mg.

Also contains: purified water, glycerol (E422), maltitol liquid (E965), sodium citrate, domiphen bromide, apple flavour.

PL 00014/5236 Text prepared 4/15 Manufactured for the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA by BCM Ltd Nottingham NG2 3AA



5 000167 081473 >


LOT & USE BY OVERPRINTED BY FACTORY


Lot:

Use By:


(2BHCZ



r Read all of this carton for full instructions^

What this medicine is for !

] This medicine contains Sodium i Bicarbonate, which belongs to a group of | 1 medicines called antacids. It can be used to ] relieve wind and griping pain in babies. j

; Before you give this medicine;

pfDo not give:

i • If your child is under 1 month old or i

] 1 year and over

I • If your child is allergic to any of fhe

i ingredients    i

' • If your child has liver or kidney problems 1 i If your child has high blood pressure, i heart failure, or fluid retention ' • If your child has low levels of calcium in I the blood, or you have been told their blooc( i is too alkaline    i

1 If your child is producing too much of a 1 | hormone from the adrenal gland i • If your child is not producing enough i 1 stomach acid

| • If your child is on a low salt (sodium) i diet (each 5 ml spoonful contains 15 mg of1 sodium, which may be harmful to your child)' | • If your child has an intolerance to somej i sugars, unless your doctor tells you to , 1 (this medicine contains maltitol liquid)

' If your child takes other medicines!

| Before you give this liquid, make sure that j i you tell your pharmacist about ANY other i ' medicines you might be giving your child at' | the same time, particularly the following: i • Salicylates (such as aspirin, for Kawasaki’s , ' Disease)

| • Tetracyclines (for bacterial infections) i • Barbiturates (for epilepsy)    i

1 If you are unsure about interactions with any ' ] other medicines, talk to your pharmacist. Tnisj i includes medicines prescribed by your doctor, 1 and medicine you have bought for your child,' ] including herbal and homeopathic remedies, j

| Information for people with diabetes: 1

i This medicine contains 0.3 g of maltitol per | i 5 ml spoonful. This provides 1 kcal per 5 mli [ spoonfuL___________________;

ARTWORK TEXT SIZE


Main Headings:

12pt

Sub Headings:

10pt

Body Copy:

8pt


/How to give this medicine

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

Use the measuring spoon provided (the big end of the spoon measures 5 ml).

Give this medicine to your baby to swallow. Do e<i ndd this medicine to feeds or bottles.


Ink & Varnish Free


Age •

How much

How often to give

11#5

5 ml

Before or after each

mostly

feed, if you need to.

• •

Don’t give more

than 6 times in 24

hours.

6t»11

10ml

Before or after each

mont: .3

feed, if you need to.

Don’t give more

• •

than 6 times in 24

_m_

hours.


Do not give 1) bahies under 1 month.

Do nc* give to babies of 1 year and over.

Do, iot give i ■ ic, & ihan the amount rec mmendc j above.

If symptoms Jo not go away talk to your pha macist or doctor.

? If you give too much: Talk to a doctor straig! t away - your baby may be drowsy, irritL.b,o, .lave a fever or breathing problems. • • ••

Possible oide effects

Most people a"! not have problems, but some may got so. ne.

? If your child guts any of these serious side uflocts, step giving the liquid.

Sec i dock r at once:

•    Difficulty oreu.hing, swelling of the face, neck, tongu' or throat (severe allergic reaction)

! If tc o ir uch is given, or too often, your baby may get:

•    Chnger in the chemistiy of the blood - your baby may be drowsy, irritable, or have breothng proDleme - talk to a doctor straight away if you notice this


PHARMACEUTICALS


GRIPE MixturB

1 MONTH PLUS

Sodium Bicarbonate


y Relief of wind and griping pain >/ For use before or after feeds


_1_50mie


23-18-415


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

•    Other allergic reactions (e.g. skin rash)

•    Stomach cramps, being sick, burping, wind

•    Your child may appear generally unwell (e.g. lacking in energy, feverish)

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 on this carton. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.ukA/ellowcard. By reporting side effects you can help provide more information on the safely of this medicine.

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.

Throw away any Gripe Mixture remaining 12 weeks after opening.

Active ingredient

Each 5 ml of liquid contains Sodium Bicarbonate 50 mg.

Also contains: purified water, glycerol (E422), maltitol liquid (E965), sodium citrate, domiphen bromide, apple flavour.

PL 00014/5236 Text prepared 4/15 Manufactured for the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA by BCM Ltd Nottingham NG2 3AA



5 000167 081473 >


LOT & USE BY OVERPRINTED BY FACTORY


Lot:

Use By:


(2BHCZ


\


BRAILLE CONVERSION - English Alphabet


• ••

• •

• • •

• •

• •

• •

• •

• • •

• • •

• •

• •

• • •

• •

• •

• •

• •

• •


Read all of this carton for full instructions^

What this medicine is for

This medicine contains Sodium Bicarbonate, which belongs to a group of medicines called antacids. It can be used to relieve wind and griping pain in babies.

Before you give this medicine

p(Do not give:

   If your child is under 1 month old or

1 year and over

   If your child is allergic to any of fhe

ingredients

   If your child has liver or kidney problems

   If your child has high blood pressure, heart failure, or fluid retention

   If your child has low levels of calcium in the blood, or you have been told their blooc( is too alkaline

   If your child is producing too much of a hormone from the adrenal gland

   If your child is not producing enough stomach acid

•    If your child is on a low salt (sodium) diet (each 5 ml spoonful contains 15 mg of sodium, which may be harmful to your child)'

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

If your child takes other medicines

Before you give this liquid, make sure that you tell your pharmacist about ANY other medicines you might be giving your child at the same time, particularly the following:

•    Salicylates (such as aspirin, for Kawasaki’s Disease)

•    Tetracyclines (for bacterial infections)

•    Barbiturates (for epilepsy)

If you are unsure about interactions with any ' other medicines, talk to your pharmacist. Tnisj includes medicines prescribed by your doctor, and medicine you have bought for your child, including herbal and homeopathic remedies.

Information for people with diabetes:

This medicine contains 0.3 g of maltitol per 5 ml spoonful. This provides 1 kcal per 5 ml spoonfuj.___________________


Boots Gripe Mixture “1 Month Plus


ARTWORK TEXT SIZE


Main Headings:    12pt

Sub Headings:    10pt

Body Copy:    8pt


Ink & Varnish Free

BRAILLE CONVERSION - English Alphabet


• • ••• • • • • •


• •••••• • •• •• •

• • • ••••••


• •


• • •


• • • •

• •• ••


• • • • •


Boots Gripe Mixture “1 Mouth Plus


ARTWORK TEXT SIZE


Main Headings:

12pt

Sub Headings:

10pt

Body Copy:

8pt


Ink & Varnish Free

ARTWORK TEXT SIZE


Main Headings:

12pt

Sub Headings:

10pt

Body Copy:

8pt


55 mm



GRIPE Mixture 1 MONTH PLUS

Sodium Bicarbonate


Read ancfkeep carton for fuHinstructions.

/How to give this medicine

Check the seal is not broken before first use.

If it is, do not give the medicine.

Use the measuring spoon provided (the big end of the spoon measures 5 ml).

Give this medicine to your baby to swallow. Do not add this medicine to feeds or bottles.


>/ Relief of wind and griping pain

y For use before or after feeds


Age

How

much

How often to give

1 to 5 months

5 ml

Before or after each feed, if you need to. Don’t give more than 6 times in 24 hours.

6 to 11 months

10 ml

Before or after each feed, if you need to. Don’t give more than 6 times in 24 hours.

Do not give to babies under 1 month.

Do not give to babies of 1 year and over.


Do not give more than the amount stated in ” " the table.

If symptoms do not go away talk to your pharmacist or doctor.

How to store this medicine

Do not store above 25eC.

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

Use by the date on the label edge.

Throw away any Gripe Mixture remaining 12 weeks after opening.

Active ingredient

Each 5 ml of liquid contains Sodium Bicaibonate 50 mg. Also contains: maltitol liquid (E965), sodium citrate.

PL 00014/5236 The Boots Company PLC Nottingham NG2 3AA


150 mie



Xi


ARTWORK ONLY

ARTWORK TEXT SIZE


Main Headings:

8pt

Sub Headings:

?Pt

Body Copy:

6pt


PACK MOCK OP

Product Name: Gripe Mixture 1 Month Pius

Product Licence No.: PLOOOU/5236R Wording Ref: BTC99360vA20/01/12

Status:

MHRA approved

Pack Details

Clear polythene terephthalate bottle with polypropylene child resistant closure fitted with an expanded polyethylene liner.

Pack Size:

ISO ml.

Version No.

Date Issued

Reason For Change

1

06/02/2014

SPC update to bring it line with the CCDS


Trident Reference No: BTC99360

Zen Ref:

TR550046

Category:

Healthcare

Sub-Category:

Childrens OTC

Brand:

Core

Pack Type:

Label

Variant:

Gripe Mixture 1 month plus

Action:

B

Date:

11/02/14

Country:

UK

Component Code:

WWXW1

Item Code:

23-18-415

CAD Ref No:

140x55mm

Printer:

N/A

Substrate:

White Paper Label

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:

0011010111(1238)

Technical Et Non Printing Items Cutter | Guides

Colours


Process Blac

PANTONE 265 C

PANTONE 351 C

Mirror Sheer Silver

1

_2_

_3_

_4_

Pattern Gloss Varnish

_5_