Label: INFANT GAS RELIEF- simethicone suspension/ drops

  • NDC Code(s): 46122-547-03
  • Packager: AMERISOURCEBERGEN DRUG CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 18, 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 and dispense liquid slowly into baby’s mouth, toward inner cheek
    • dosage can also be mixed with 1 oz. of cool water, infan 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 (over 2)24 and over0.6 mL

  • Other information

    • 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

    1

  • INGREDIENTS AND APPEARANCE
    INFANT GAS RELIEF 
    simethicone suspension/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-547
    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
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MALTITOL (UNII: D65DG142WK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-547-031 in 1 CARTON11/16/2018
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00206/01/2018
    Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(46122-547)
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