Infants Gas Relief
FDA Label NDC 0363-5773

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Infants Gas Relief (NDC 0363-5773). 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:
WALGREEN CO.
200 WILMOT ROAD
DEERFIELD, IL 60015

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
  • only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into hole at top of bottle and turn upside down. Pull back plunger of syringe until syringe filled slightly over prescribed level. Turn to original position, simply push plunger back until you have reached the prescribe level. Pull syringe out of the bottle 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 syringe 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 preprinted seal around the bottle 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, Sodium Benzoate, Sodium Citrate, Sucralose

Questions Or Comments?

1-800-Walgreens (1-800-925-4733)

Principal Display Panel - 2-Bottle Carton

TWIN PACK X 1 FL OZ = 2 FL OZ

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDED‡

Infants'

Gas Relief

Simethicone 20 mg/Dose
Anti-Gas

• Nonstaining formula • No alcohol

• No saccharin • No artificial flavor

• New dosing syringe design

200 DOSES

Compare to Infants' Mylicon®
Drops active ingredient‡‡

2-1 FL OZ (30 mL) BOTTLES  TOTAL 2 FL OZ (60 mL)

Principal Display Panel (2-Bottle Carton)

Principal Display Panel (2-Bottle Carton)

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