Label: INFANTS GAS DROPS- simethicone suspension/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 30, 2018

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  • 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.

  • 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 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

  • Principal Display Panel

    Gas Drops Label

  • INGREDIENTS AND APPEARANCE
    INFANTS GAS DROPS 
    simethicone suspension/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-523
    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
    SODIUM (UNII: 9NEZ333N27)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-523-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33203/16/1996
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-523)
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