Label: INFANTS GAS RELIEF- simethicone suspension

  • NDC Code(s): 57896-798-01
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • Active ingredient (in each 0.3 mL)

    Simethicone 20 mg

  • Purpose

    Antigas

  • Use

    relieves the symptoms referred to as gas

  • Warnings

    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 anddispense 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 240.3 mL

    children (2 and over)

    		24 and over0.6 mL

  • Other information

    • TAMPER-EVIDENT: Do not use if foil seal under the cap is broken or punctured.
    • store at room temperature
    • 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?

    1-800-540-3765

  • Package Label

    NDC 57896-798-01

    Health star

    the sensible choice for price and health

    INFANTS'
    GAS RELIEF
    DROPS

    dye free

    Simethicone Oral Suspension USP

    Antigas
    Relieves the Symptoms
    Referred to as Gas

    Plastic Dropper Enclosed
    Antigas
    Relieves the Symptoms
    Referred to as Gas
    Simethicone Oral Suspension USP
    1 FL OZ
    (30 mL)
    Compare to active
    ingredient of
    Infants MYLICON®*

    hst gas

  • INGREDIENTS AND APPEARANCE
    INFANTS GAS RELIEF 
    simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-798
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    MALTITOL (UNII: D65DG142WK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-798-011 in 1 BOX05/01/2014
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00205/01/2014
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(57896-798)
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