Label: ALUMINUM HYDROXIDE gel

  • 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 August 12, 2013

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  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL teaspoonful)
    Aluminum hydroxide 320 mg

  • PURPOSE

    Purpose
    Antacid

  • INDICATIONS & USAGE

    Uses
    For the relief of

    • heartburn
    • acid indigestion
    • sour stomach
  • WARNINGS

    Warnings

  • ASK DOCTOR/PHARMACIST

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

  • WHEN USING

    When using this product you may get constipated

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • shake well before using
    • do not take more than 12 teaspoonfuls in 24 hours
    • do not use the maximum dosage for more than 2 weeks
    • dosage: 2 teaspoonfuls 5-6 times daily after meals and at bedtime followed by a sip of water if needed
  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature
    • protect from freezing
    • keep tightly closed
  • INACTIVE INGREDIENT

    Inactive ingredients
    benzyl alcohol, butylparaben, flavor, glycerin, hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol solution

  • QUESTIONS

    Questions or comments?
    Call 1-855-333-6337

  • SPL UNCLASSIFIED SECTION

    Repackaged by:
    Safecor Health LLC
    317 New Boston St.
    Woburn, MA 01801
    Distributed by:
    LLC Federal Solutions
    14 NE 1st Ave.
    Miami, FL 33123

  • PRINCIPAL DISPLAY PANEL



    ———PRINCIPAL DISPLAY PANEL———
    NDC: 24451-091-30
    ALUMINUM HYDROXIDE
    GEL, USP
    1920 mg / 30 mL
    DELIVERS 30 mL
    SUGAR FREE
    MINT FLAVOR
    SHAKE WELL BEFORE USING
    Exp: 00/00/00 Lot # 00000

    Rpk By: Safecor Health LLC
    Woburn, MA 01801
    Dist. By: LLC Federal Solutions
    Miami, FL 33132

    product label

  • INGREDIENTS AND APPEARANCE
    ALUMINUM HYDROXIDE 
    aluminum hydroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24451-091(NDC:0536-0091)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE320 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24451-091-30100 in 1 BOX
    130 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/12/2013
    Labeler - LLC Federal Solutions (965036895)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC828269675repack(24451-091)
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