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Flacol Tab

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Flacol Tab

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®

Flacol Simethicone USP

COMPOSITION SIDE EFFECT


Flacol® Paediatric Drops: Each ml drop contains 67 mg Simethicone is physiologically inert and no adverse
Simethicone USP. Flacol® Tablet: Each chewable tablet effect has been noted after oral ingestion.
contains Simethicone USP 40 mg.
PRECAUTION
PHARMACOLOGY Keep the medicine out of the reach of children.
Flacol® (Simethicone) is used as an antiflatulent to
relieve symptoms commonly referred to gas including DRUG INTERACTION
upper GI bloating, pressure, fullness or stuffed feeling. The There is no evidence that Simethicone modifies the
clinical use of Flacol® is based on its antifoaming effect of other drugs.
properties. Its antifoaming action relieves flatulence by
dispersing and preventing the formation of mucous USE IN PREGNANCY AND LACTATION
surrounded Pregnant women: No data are available to suggest any
harmful effects.

INDICATION
1. Flatulence, abdominal distention, fullness, gas and windy colic: Flacol® is an excellent and effective antiflatulent.
It is used for relief of the painful symptoms of excess gas in the digestive tract. Such gas is frequently caused by
excessive swallowing of air or by eating foods that disagree. Flacol® drop is especially used in infants, acts in the
stomach and intestines. Thus Flacol® enables freeing and eliminating the gas more easily by belching or passing
flatus. 2. Large bowel preparation: Addition of Flacol® to a polyethylene glycol bowel preparation produces
symptomatic improvement prior to investigation in the management of accidental ingestion of foaming
detergents. 3. Treatment of poisoning: Flacol® has an anecdotal use as an antifoaming agent in the management
of accidental ingestion of foaming detergents.

DOSAGE AND ADMINISTRATION


Take after meals and at bedtime. Can be given with infant’s feeds. Shake the bottle well before each use. Children
less than 2 years of age: 20 mg (0.3 ml Flacol® Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Flacol®
Paediatric Drops). Children 2-12 years of age: 40 mg (0.6 ml Flacol® Paediatric Drops) 4 times daily. Adults: 40-125
mg. 0.6 ml-1.9 ml Flacol® Paediatric Drops; 4 times daily, up to 500 mg/day (7.5 ml Flacol® Paediatric Drops) or
1-3 Flacol® chewable tablets; 4 times daily, up to 500 mg/day (12 Flacol® chewable tablets).

gas pockets in the GI tract. Flacol® acts in the stomach Lactating mother: Excretion of Simethicone in breast milk
and intestines to change the surface tension of gas has not been established, and would be most unlikely.
bubbles, enabling them to coalesce; thus gas is freed and
eliminated more easily by belching or passing flatus.
Flacol® aids in the elimination of gas from the GI tract STORAGE CONDITION
and can be used to reduce postoperative gas pains. Should be stored in cool and dry place, protected from
Flacol® can also be used prior to gastroscopy to enhance light.
visualization and prior to radiography of the intestine to
reduce gas shadows. HOW SUPPLIED
Flacol® Paediatric drops: Bottle containing 15 ml drops
with plastic dropper. Flacol® Tablet: Each box contains
50 chewable tablets.

Revision No.: 03

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