Label: ALUMINUM HYDROXIDE 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 15, 2017

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 5 mL teaspoonful)

    Aluminum hydroxide 320 mg

  • Purpose

    Antacid

  • Uses

    relieves

    • heartburn
    • acid indigestion
    • sour stomach

  • Warnings

    Ask a doctor or pharmacist before use if you are taking a prescription drug.

    Antacids may interact with certain prescription drugs.
    When using this product you may get constipated

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

    Keep out of reach of children.

  • 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 information

    • store at room temperature
    • protect from freezing
    • keep tightly closed
    • TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING.
  • Inactive ingredients

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

    Questions or comments?

    1-800-645-2158

  • package Label

    compare to the active ingredient in AMPHOJEL

    Rugby

    NDC 0536-0091-85
    MINT FLAVOR

    Aluminum Hydroxide Gel, USP

    ANTACID
    SUGAR FREE
    This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
    Rugby Laboratories, INC. is not affiliated with the owner of the trademark Amphojel.
    16 fl oz (473 mL)

    rug al

  • INGREDIENTS AND APPEARANCE
    ALUMINUM HYDROXIDE 
    aluminum hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-0091-85473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/01/2005
    Labeler - Rugby Laboratories (079246066)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(0536-0091)