Woodward's gripe water

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium bicarbonate; Dill seed oil terpeneless

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

INN (International Name):

Sodium bicarbonate; Dill seed oil terpeneless

Dosage:

10.5mg/1ml ; 460microgram/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01010102; GTIN: 5012509978372

Summary of Product characteristics

OBJECT 1
WOODWARDS GRIPE WATER - ALCOHOL FREE & SUGAR
FREE
Summary of Product Characteristics Updated 12-Jun-2017 | Reckitt
Benckiser Healthcare (UK) Ltd
1. 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
Excipients:
Maltitol Liquid
Sodium
Sodium ethyl p-hydroxybenzoate (E215)
Sodium propyl p-hydroxybenzoate (E217)
Sodium methyl p-hydroxybenzoate (E219)
For a full list of 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.
Patients with rare hereditary problems of fructose intolerance should
not take this medicine.
Label must include equivalent sentences of:
This medicinal product contains 1.4mmol (or 32.2mg) sodium per dose.
To be taken into consideration by
patients on a controlled sodium diet.
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor
before taking this medicinal product.
This medicine contains hydroxybenzoate derivatives (E215, E217 and
E219) which may cause allergic
reactions (possibly delayed).
4.5 Interaction with other medicinal products and other forms of
interaction
None known
4.6 Fertility, pregnancy and lactation
Not applicable
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Un