Active Ingredient (In Each 0.3 Ml)
Simethicone 20 mg
Infants Gas Relief Solution/ Drops
FDA Label NDC 69256-520
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter, Llc for the product Infants Gas Relief (NDC 69256-520). 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 ingredient 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 Ingredient Section
benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum.
Principal Display Panel
Harris Teeter™
NDC 69256-520-09
INFANTS'
GAS RELIEF DROPS
Antigas
Simethicone 20 mg
Fast Relief of Gas Symptoms
No Artificial Flavor
Alcohol Free
Dye Free
Gentle & Safe**
Compare to the Active Ingredient in Mylicon®
Non-Staining Infants' Drops*
**Use only as directed;
do not exceed 12 doses per day.
1 FL OZ (30mL)
520-ht.jpg (520 Ht)
* Please review the disclaimer below.
