INFANTS GAS DROPS- simethicone suspension/ drops

Infants Gas Drops by

Drug Labeling and Warnings

Infants Gas Drops by is a Otc medication manufactured, distributed, or labeled by Rij Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

  • © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.