Label: ACID GONE ANTACID- aluminum hydroxide and magnesium carbonate 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 13, 2017

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  • Active ingredient (in each 15mL tablespoonful)

    Aluminum hydroxide 95mg

    Magnesium carbonate 358mg

  • Purpose

    Antacid

  • Uses

    relieves

    • heartburn
    • acid indigestion
    • sour stomach
    • upset stomach associated with these symptoms
  • Warnings

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet
    • a sodium-restricted diet

    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

    • do not take more than 8 tablespoonfuls in 24 hours
    • do not use the maximum dosage for more than 2 weeks
    • laxative effect may occur

    If pregnant or breast-feeding, ask a health professional before use.

  • 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 use
    • adults and children 12 years and older: take 1 to 2 tablespoonfuls four times a day or as directed by a doctor
    • children under 12 years: ask a doctor
    • take after meals and at bedtime
    • dispense product only by spoon or other measuring device
  • Other information

    • each 15 mL tablespoonful contains: magnesium 105mg, sodium 39mg
    • store at up to 25°C (77°F)
    • avoid freezing
    • keep tightly closed
    • TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is broken or missing.
  • Inactive ingredients (Regular Strength)

    benzyl alcohol, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, purified water, saccharin sodium, sodium alginate, sorbitol solution, xanthan gum

  • Questions or comments?

    1-800-540-3765

  • Principal Display Panel

    major

    NDC 0904-7727-14

    Acid Gone Antacid

    Alumina and Magnesium Carbonate
    Oral Suspension USP

    Relieves Heartburn
    & Acid Indigestion

    Compare to the active ingredients in Gaviscon® *

    12 FL OZ (355 mL)

    MAJ

  • INGREDIENTS AND APPEARANCE
    ACID GONE ANTACID 
    aluminum hydroxide and magnesium carbonate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7727
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE95 mg  in 15 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE358 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorSPEARMINT (cool mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7727-14355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/30/2004
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(0904-7727)
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