FDA Label for Infants Gas Drops
View Indications, Usage & Precautions
Infants Gas Drops Product Label
The following document was submitted to the FDA by the labeler of this product Rij Pharmaceutical Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 0.3Ml)
Simethicone 20 mg
Purpose
Antigas
Uses
Relieves the discomfort of gas frequently caused by air swallowing, or certain formulas or foods.
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 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• for best results, clean dropper after each use and replace original cap.
| Age (yrs) | Weight (lbs) | Dose (ml) |
|---|---|---|
| Infants under 2 | Under 24 | 0.3 mL |
| Children over 2 | Over 24 | 0.6 mL |
Other Information
- TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
• Store at room temperature 15° - 30°C (59 - 86°F)• protect from freezing• each 0.3 mL contains: sodium 1 mg
Inactive Ingredients
carbopol - 934-P, citric acid, FD&C red #3, flavor, hypromellose, sodium benzoate, sodium citrate, sodium hypoclorite, sodium saccharin, water
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