Active Ingredient (In Each 0.3 Ml)
Simethicone 20 mg
Infants Gas Relief Suspension
FDA Label NDC 57896-798
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceuticals, Corp for the product Infants Gas Relief (NDC 57896-798). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Use
relieves the symptoms referred to as gas
Otc - Keep Out Of Reach Of Children
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, or as directed by a physician
- do not exceed 12 doses per day
- fill enclosed dropper to recommended dosage level anddispense liquid slowly into baby’s mouth, toward the inner cheek dosage can also be mixed with 1 oz. of cool water, infant 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 (2 and over) | 24 and over | 0.6 mL |
Other Information
- TAMPER-EVIDENT: Do not use if foil seal under the cap is broken or punctured.
- store at room temperature
- do not freeze
- see bottom panel for lot number and expiration date
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum
Questions Or Comments?
1-800-540-3765
Package Label
NDC 57896-798-01
Health star
the sensible choice for price and health
INFANTS'
GAS RELIEF
DROPS
dye free
Simethicone Oral Suspension USP
Antigas
Relieves the Symptoms
Referred to as Gas
Plastic Dropper Enclosed
Antigas
Relieves the Symptoms
Referred to as Gas
Simethicone Oral Suspension USP
1 FL OZ
(30 mL)
Compare to active
ingredient of
Infants MYLICON®*
* Please review the disclaimer below.
