Active Ingredient (In Each 0.3 Ml)
Simethicone 20 mg
Infants Gas Relief Solution/ Drops
FDA Label NDC 36800-119
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Infants Gas Relief (NDC 36800-119). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 0.3 ml), purpose, use(s), warnings, keep out of reach of children, directions, other information, inactive ingredients section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Use(S)
relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods
Warnings
When using this product do not exceed 12 doses per day
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away
Directions
- shake well before using
- all dosages may be repeated as needed, after meals and at bedtime
- 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 |
Other Information
store at room temperature
Inactive Ingredients Section
benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum
Principal Display Panel
Topcare health
COMPARE TO MYLICON® NON-STAINING INFANTS' DROPS ACTIVE INGREDIENT*
NDC 36800-119-09
NON-STAINING
DYE-FREE
infants'
Gas Relief
Drops
SIMETHICONE 20 mg
ANTI-GAS
- Gently Breaks Down Baby's Gas Bubbles
- Safe Enough to Use at Every Feeding**
**use as directed
1 FL OZ (30 mL)
74 (520 New)
* Please review the disclaimer below.
