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INFANTS GAS RELIEF (MAJOR Pharmaceuticals Inc.)

Available Formats

Dosage Form Package Information Links
SUSPENSION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (0904-5894-30) > 30 mL in 1 BOTTLE, DROPPER Label Information

Complete INFANTS GAS RELIEF Information

  • 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, infant formula or other suitable liquids
    • clean dropper well after each use and replace original cap

    Age (years) Weight (lbs) Dose
    infants (under 2)
    under 24
    0.3 mL
    children (2 and over)
    24 and over
    0.6 mL

  • Other information

    •   TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing.
    • store at room temperature
    • do not freeze
    • see bottom panel for lot number and expiration date

  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, maltitol, microcrystalline cellulose, flavor, purified water, sodium benzoate, sodium citrate, xanthan gum

    Questions or comments?

    (800)616-2471


  • package Label

    NDC 0904-5894-30

    MAJOR
    INFANTS' GAS RELIEF DROPS

    Simethicone Oral Suspension USP
    Anti gas
    relieves the symptoms referred to as gas
    dye free
    plastic dropper enclosed
    compare to active ingredient in MYLICON infants drops*
    1 FL OZ (30 mL)

    mj


  • INGREDIENTS AND APPEARANCE
    INFANTS GAS RELIEF 
    simethicone suspension/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5894
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MALTITOL (UNII: D65DG142WK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color white (off-white) Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5894-30 1 in 1 CARTON 12/01/2016
    1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 12/07/2010
    Labeler - MAJOR Pharmaceuticals Inc. (191427277)
    Registrant - GCP Laboratories (965480861)
    Establishment
    Name Address ID/FEI Business Operations
    GCP Laboratories 965480861 manufacture(0904-5894)