Active Ingredient (In Each 0.3 Ml)
Simethicone 20 mg
Infants Non Staining Gas Relief Solution/ Drops
FDA Label NDC 72476-520
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Retail Business Services, Llc. for the product Infants Non Staining Gas Relief (NDC 72476-520). 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 ingredients, 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
benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum
Principal Display Panel
CareOne™
Compare to the Active Ingredient in Mylicon® Drops Dye-Free Formula*
Infants'
GAS RELIEF
Simethicone 20 mg/Antigas
Safe to use at every feeding**
Non-staining Formula
No Artificial Flavor
No Alcohol
No Saccharine
Dye Free
**Use As Directed;
1 FL OZ (30mL)
520-01-care.jpg (520 01 Care)
* Please review the disclaimer below.
