Infant Sugar Free Simple Cough Linctus
Prepared for Yellow Card submission June 2015 Page 1
Carton for Children’s 3 Month Plus Simple Cough Linctus PL 00014/0500
Children’s 3 Month Plus Simple Cough Linctus Glycerol
APPLE FLAVOUR
S Soothes and relieves dry, tickly coughs COLOUR FREE SUGAR FREE 100 ml e
Read all of this carton for full instructions.
What this medicine is for
This medicine contains Glycerol, which has soothing properties. It can be used to soothe and relieve the irritation caused by dry, tickly coughs.
Before you give this medicine
X Do not give:
• If your child is under 3 months
• If your child is allergic to any of the ingredients in the medicine
• If your child has an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol liquid which may have a mild laxative effect)
Information for people with diabetes: This medicine contains 1.9 g maltitol liquid per 5 ml spoonful. This provides 4 kcal per 5 ml spoonful.
Information for adults intending to take this medicine
All of the information on this carton will apply to you as well.
You can take this medicine if you are pregnant or breastfeeding.
S 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 small end measures 2.5 ml and the big end measures 5 ml).
|
Age |
How much to give |
How often to give |
|
Children of 3 to 11 months |
5 ml |
Three to four times a day |
|
Children of 1 to 5 years |
10 ml |
Three to four times a day |
Give this medicine to your child to swallow.
Do not give to children under 3 months.
Do not give more than the amount recommended above.
If symptoms do not go away within 3 days talk to your doctor. If you give too much: Talk to a pharmacist or doctor.
Carton for Children’s 3 Month Plus Simple Cough Linctus PL 00014/0500
Possible side effects
Most people will not have problems.
! If your child gets any of these serious side effects, stop giving the medicine. See a doctor at once:
• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions) 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.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store this medicine
Keep tightly closed.
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 syrup contains Glycerol 0.75 ml.
Also contains: purified water, maltitol liquid (E965), citric acid, hyetellose, sodium citrate, sodium benzoate (E211), apple flavour.
PL 00014/0500 Text prepared 05/15
Manufactured by BCM Ltd Nottingham NG2 3AA for the MAH: The Boots Company PLC Nottingham NG2 3AAOther formats
To request a copy of this carton in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Children’s 3 Month Plus Simple Cough Linctus Reference number: 00014/0500
This is a service provided by the Royal National Institute of Blind People.
If you need more advice ask your pharmacist.
Lot:
Use By:
Bar code Item code Component code
PACK MOCK UP BOX
Product Name: Children’s 3 Month Plus Simple Cough Linctus Product Licence No: 00014/0500 Wording Ref: Internal draft for Yellow Card Status: Mock-Up Internally Approved
Pack details: Amber PET bottle with polypropylene child resistant closure fitted with an expanded polythene liner.
Carton for Children’s 3 Month Plus Simple Cough Linctus PL 00014/0500
Pack Size: 100 ml
Version No: 1
Date issued: June 2015
Reason for change: Non-Marketed tradename A4 text for MHRA submission to add Yellow Card reporting statement (15-096)