Woodward's Gripe Water - Alcohol Free & Sugar Free

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DILL SEED, OIL TERPENELESS, SODIUM HYDROGEN, CARBONATE

Available from:

Seton Products Limited Tubiton House, Medlock Street, Oldham, United Kingdom

ATC code:

A16A

INN (International Name):

DILL SEED OIL TERPENELESS 2.3 mg/5ml SODIUM HYDROGEN CARBONATE 52.5 mg/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

DILL SEED OIL TERPENELESS 2.3 mg/5ml SODIUM HYDROGEN CARBONATE 52.5 mg/5ml

Prescription type:

OTC

Therapeutic area:

OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-11-02

Patient Information leaflet

Summary of Product characteristics

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Woodward’s Gripe Water - Alcohol Free & Sugar Free 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Terpeneless Dill Seed Oil 2.3mg/5ml 
Sodium Hydrogen Carbonate 52.5mg/5ml 

For excipients, see 6.1 

3. PHARMACEUTICAL 
FORM 

Oral solution 

4. CLINICAL 
PARTICULARS 

4.1. THERAPEUTIC 
INDICATIONS 

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

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

For oral use 

Adults & the Elderly: Not applicable 

Children: 
1 - 6 months old 
- 
One 5ml spoonful 

6 - 12 months old 
- 
Two 5ml spoonsful 

Under one month old  - 
Not to be used 

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

4.3. CONTRAINDICATIONS 

Should not be used where impaired kidney function
or hypersensitivity to hydroxybenzoates 
exists. 

4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

If symptoms persist, medical advice should be sought. 
Keep all medicines out of the reach of children 

Page 2 of 4 
4.5. 
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF
INTERACTION 

None known. 

4.6. 
PREGNANCY AND LACTATION 

Not applicable. 

4.7. 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 

Not applicable. 

4.8. UNDESIRABLE 
EFFECTS 

None known. 

4.9. OVERDOSE 

Symptoms following overdose are rare and are generally due to
the effects of sodium 
hydrogen carbonate.  These may include diarrhoea, metabolic
alkalosis and hypernatraemia.  
In the event of severe overdosing, medical
advice should be sought immediately. 

Symptoms of hypernatraemia may include drowsiness and
irritability, pyrexia and 
tachypnoea.  In more severe instances of acute sodium overload,
signs of dehyd