Label: GELFOS-M- aluminum phosphate, colloidal, magnesium hydroxide, simethicone liquid

  • 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 November 21, 2018

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  • ACTIVE INGREDIENT

    Aluminum Phosphate, Colloidal

    Magnesium Hydroxide

    Simethicone

  • PURPOSE

    ■ sour stomach ■ acid indigestion ■ upset stomach associated with these

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    ■ take 2-3 envelops as symptoms accur, as directed by a doctor

  • WARNINGS

    Warnings

    Ask a doctor before use if you have taking a prescription drug. Antacids may interact with certain prescription drugs

    When using this product

    ■ Do not take more than 4 envelop in 24 hours

    ■ Do not use the maximum dosage for more than 2 weeks

  • INACTIVE INGREDIENT

    water, sugar, agar, pectin, essence of orange, calcium

  • DOSAGE & ADMINISTRATION

    For oral use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    GELFOS-M 
    aluminum phosphate, colloidal, magnesium hydroxide, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM PHOSPHATE (UNII: F92V3S521O) (ALUMINUM PHOSPHATE - UNII:F92V3S521O) ALUMINUM PHOSPHATE12.38 g  in 20 g
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 20 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 20 g
    Inactive Ingredients
    Ingredient NameStrength
    PECTIN (UNII: 89NA02M4RX)  
    WATER (UNII: 059QF0KO0R)  
    AGAR (UNII: 89T13OHQ2B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0008-14 in 1 PACKAGE11/15/2018
    120 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/15/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468manufacture(72689-0008) , relabel(72689-0008)
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