Infants Non-staining Gas relief
Infants Non-staining Gas relief is an FDA drug label for the active ingredient SIMETHICONE manufactured by H E B 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 20231204.
- Generic name
- SIMETHICONE
- Manufacturer
- H E B
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 37808-014
- Application
- part332
- Label effective
- 20231204
Active ingredients
Indications & Usage
USE(S) relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods
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. fill enclosed dropper to recommended dosage level dispense liquid slowly into baby's mouth, toward the inner cheek may mix with 1 oz. of cool water, infant formula or other suitable liquids. clean dropper after each use and close the bottle to maintain child resistance age (yr) weight (lb) dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL
Contraindications
Not available.
Warnings
WARNINGS When using this product do not exceed 12 doses per day
Adverse Reactions
Not available.