Infants Gas Drops
FDA Label NDC 53807-523

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Infants Gas Drops (NDC 53807-523). 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 ingredients (in each 0.3ml), purpose, uses, 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

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 2Under 240.3 mL
    Children over 2Over 240.6 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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