Label: INFANTS GAS RELIEF DROPS- simethicone suspension/ drops

  • NDC Code(s): 69618-059-51
  • Packager: RELIABLE 1 LABORATORIES
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 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
    • only use the enclosed dropper
    • 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
    • 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 missing.
    • store between 20°-25°C (68°-77°F)
    • 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?

    call 516-341-0666
    8:30 am - 4:30 pm ET,
    Monday - Friday

  • package Label

    1

  • INGREDIENTS AND APPEARANCE
    INFANTS GAS RELIEF DROPS 
    simethicone suspension/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-059
    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
    Colorwhite (off-white) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-059-511 in 1 CARTON02/01/2020
    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 DrugM00202/01/2020
    Labeler - RELIABLE 1 LABORATORIES (079718111)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(69618-059)
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