INFANT GAS RELIEF

INFANT GAS RELIEF is an FDA drug label for the active ingredient SIMETHICONE manufactured by AMERISOURCEBERGEN DRUG CORPORATION administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230718.

Generic: SIMETHICONE

Manufacturer: AMERISOURCEBERGEN DRUG CORPORATION

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 46122-547

Application: M002

Effective: 20230718

Active Ingredients: Active ingredient (in each 0.3 mL) Simethicone 20 mg

Indications & Usage

Use relieves the symptoms referred to as gas

Dosage & Administration

Directions shake well before using all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician do not exceed 12 doses per day fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek dosage can also be mixed with 1 oz. of cool water, infan formula or other suitable liquids clean dropper well after each use and replace original cap on bottle Age (years) Weight (lbs) Dose infants (under 2) under 24 0.3 mL children (over 2) 24 and over 0.6 mL

Contraindications

Not available.

Warnings

Warnings Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Adverse Reactions

Not available.

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