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Infant Gripe Water

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PIL TEXT

WOODWARD’S GRIPE WATER

ALCOHOL & SUGAR FREE

Woodwards Gripe Water - Alcohol & Sugar Free contains the following active ingredients:

Terpenless Dill Seed Oil 2.3mg/5ml Sodium Bicarbonate BP 52.5mg/5ml

In addition, it also contains the following ingredients:

Glycerol EP Activated Dimethicone Polysorbate 80 Malitol Solution

Sodium Methylhydroxybenzoate (E219)

Sodium Propylhydroxybenzoate (E217)

Disodium EDTA Purified Water

Pharmaceutical Form

A clear colourless to very pale straw liquid in a clear glass tamper-proof bottle containing 150ml of product.

Product Type

Woodwards Gripe Water - Alcohol & Sugar Free acts as an antacid and carminative.

Dill seed Oil is a carminative. Carminatives have the properties of warming and relaxing the tummy allowing the upward passage of trapped wind.

Sodium Bicarbonate is an antacid. It neutralises excess acid in the stomach.

Product Licence Holder

Ayrton Saunders Ltd.,

North Way, Walworth Industrial Estate,

Andover,

Hampshire SP 10 5AZ Manufacturer:

Wrafton Laboratories Ltd., Wrafton, Braunton, North Devon, EX33 2DL William Ransom & Son Plc., 104 Bancroft, Hitchin, Hertfordshire, SG5 1LY

Uses

For the symptomatic relief of distress associated with wind and gripe in infants up to one year old.

BEFORE USING WOODWARDS GRIPE WATER - ALCOHOL AND SUGAR FREE

The following information should be read before using this product:

1.    Do not use this product on a baby who is sensitive to any of the ingredients listed at the beginning of this leaflet

2.    Make sure this product is suitable for your baby to use - ask your doctor or pharmacist.

3.    Do not use on babies under one month unless on a doctors advice.

4.    Do not use this product if kidney problems persist.

5.    If symptoms persist, consult your doctor.

DIRECTIONS FOR USING WOODWARDS GRIPE WATER - ALCOHOL & SUGAR FREE

Babies up to 1 month old:    Not to be used

1 - 6 months old:    One 5ml spoonful

6-12 months old:    Two 5ml spoonfuls

These doses may be given during or after each feed, up to six times in 24 hours.

Adults and the elderly:    Not applicable

What if too much is taken?

In the event of accidental or deliberate overdose, medical attention should be sought immediately.

AFTER TAKING WOODWARDS GRIPE WATER - ALCOHOL & SUGAR FREE

No side effects have been reported following use of this product.

Should your baby experience any form of reaction, stop using this product immediately and report it to your doctor or pharmacist who will advise you of the necessary action to take.

STORING YOUR PRODUCT

This product, whilst unopened has a one year shelf life which is given on the bottle label. Discard the contents of this bottle one month after opening.

Do not use Woodwards Gripe Water - Alcohol & Sugar Free after the expiry date shown on the label.

Woodwards Gripe Water - Alcohol & Sugar Free should be stored below 25°C, out of the reach of children.

Date of Preparation: January 2011

PL 16431/0154