Active Ingredient (In Each 0.3 Ml)
Simethicone 20 mg
Infants Gas Relief Drops Suspension/ Drops
FDA Label NDC 69618-059
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories for the product Infants Gas Relief Drops (NDC 69618-059). 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, warnings, otc - 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
relieves the symptoms referred to as gas
Warnings
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
- only use the enclosed dropper
- do not exceed 12 doses per day
- fill enclosed dropper to recommended dosage level and dispense 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 missing.
- store between 20°-25°C (68°-77°F)
- 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?
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Package Label
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