Infants Gas Relief
FDA Label NDC 59779-701

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Infants Gas Relief (NDC 59779-701). 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 other, active ingredient (in each 0.3 ml), 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

Other

Drug Facts

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

Active Ingredient (In Each 0.3 Ml)

Simethicone 20 mg

Purpose

Anti-gas

Uses

Relieves the discomfort of infant 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. (1-800-222-1222)

Directions

  • shake well before using
  • all doses 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 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 (yr)Weight (lb)Dose
    infants under 2under 240.3 mL
    children over 2over 240.6 mL

Other Information

  • do not use if printed foil seal under cap is torn or missing
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive Ingredients

Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Red #3, Sodium Benzoate, Sodium Citrate, Sucralose

Principal Display Panel - 30 Ml Bottle Carton

CVS
pharmacy®

Compare to the
active ingredient in
Infants' MYLICON® Drops*

Infants'
GAS
RELIEF
ORIGINAL FORMULA

SIMETHICONE/ANTIGAS

  • No alcohol
  • No saccharin
  • No artificial flavor

    • 100 Doses
    1 FL OZ (30 mL)

    Principal Display Panel (30 mL Bottle Carton)

    Principal Display Panel (30 mL Bottle Carton)

* Please review the disclaimer below.