Label: ALMACONE- aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable

  • 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 December 1, 2010

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  • ACTIVE INGREDIENT

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    Active ingredients (in each tablet)                          Purpose

    Aluminum Hydroxide (dried gel) 200mg ...........        Antacid

    Magnesium Hydroxide 200mg ............                        Antacid

    Simethicone 20 mg ..............                                        Antigas


  • PURPOSE

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    Purposes

    Antacid

    Antigas

  • KEEP OUT OF REACH OF CHILDREN

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    Keep out of reach of children.

  • INDICATIONS & USAGE

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    Uses relieves

    • heartburn
    • acid indigestion
    • sour stomach
    • gas associated with these conditions
  • WARNINGS

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    Warnings

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium restricted diet
    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
  • STOP USE

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    Stop use and ask a doctor if symptoms last more than 2 weeks.

  • DOSAGE & ADMINISTRATION

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    dosage: chew 2 - 4 tablets between meals and at bedtime.

    do not take more than 24 tablets in a 24 hour period.

    do not use the maximum dose for more than 2 weeks.

    each tablet contains: magnesium 82 mg


  • STORAGE AND HANDLING

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    store between 15 o - 30 o C ( 59o  - 86o F ) 

  • QUESTIONS

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    Questions or comments ?

    call 1-800-645-2158, 9am - 5pm ET, Monday - Friday

  • DO NOT USE

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    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • INACTIVE INGREDIENT

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    Inactive ingredients: dextrose, dipac sugar, microcrystalline cellulose, peppermint flavor, stearic acid

  • PRINCIPAL DISPLAY PANEL

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    display panel image

  • INGREDIENTS AND APPEARANCE
    ALMACONE 
    aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM HYDROXIDE200 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O, SILICON DIOXIDE - UNII:ETJ7Z6XBU4) DIMETHICONE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    SUCROSE (UNII: C151H8M554)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeROUND (Tablet) Size16mm
    FlavorPEPPERMINT (peppermint flavor) Imprint Code 049
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-3504-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33208/23/2010
    Labeler - Rugby Laboratories, Inc. (109178264)
    Registrant - Advance Pharmaceutical, Inc. (187824339)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical, Inc.187824339manufacture, repack, relabel
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