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INFACOL Oral suspension (2018)

Active ingredients: Simethicone

Product Name and Form

INFACOL.

Pharmaceutical form

Oral suspension.

A white/off white opaque suspension free from particulates.

Qualitative and Quantitative Composition

Active ingredient: Simeticone 40mg/ml.

Excipients with known effect:

Methyl Hydroxybenzoate (E218) 0.18% w/v

Propyl Hydroxybenzoate (E216) 0.02% w/v

For the full list of excipients, see section 6.1.

Chemical substance
Description
Simethicone

Simethicone is a chemically inert, non-systemic gastric defoaming agent that works by altering the elasticity of interfaces of mucus-embedded bubbles in the gastrointestinal tract. The gas bubbles are thus broken down or coalesced and in this form gas is more easily eliminated through eructation or passing flatus.

List of excipients

Saccharin sodium
Hypromellose
Orange flavour
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
Purified water

Pack sizes and Marketing

High-density polyethylene bottle fitted with a low-density polyethylene dropper and evoprene teat containing 50ml, 55ml, 75ml, 85ml and 100ml of liquid.

Marketing authorization holder
Authorization dates

Forest Laboratories UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom

29th October 1986 / 20 January 1997

Marketing authorization number:

PL 0108/0100