Label: GAVISCON- aluminum hydroxide and magnesium carbonate liquid

  • NDC Code(s): 0135-0094-41, 0135-0094-42, 0135-0095-41, 0135-0574-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 22, 2017

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

  • Active ingredient (in each 15mL tablespoonful) Regular Strength

    Aluminum hydroxide 95mg

    Magnesium carbonate 358mg

  • Active ingredient (in each 5mL teaspoonful) Extra Strength

    Aluminum hydroxide 254mg

    Magnesium carbonate 237.5mg

  • Purpose

    Antacid

  • Uses

    relieves

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

    Do not use if you have kidney disease

    Ask a doctor or pharmacist before use if you are

     
           have kidney disease.
     
           are on a sodium-restricted diet or a magnesium-restricted diet.
     
           are taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product (Regular Strength)

    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

    When using this product (Extra Strength)

    do not take more than 16 teaspoonfuls in 24 hours
    do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
    laxative effect may occur

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions (Regular Strength)

    shake well
    take 1-2 tablespoonfuls four times a day or as directed by a doctor
    take after meals and at bedtime
    dispense product only by spoon or other measuring device
  • Directions (Extra Strength)

    shake well
    take 2-4 teaspoonfuls four times a day or as directed by a doctor
    take after meals and at bedtime
    dispense product only by spoon or other measuring device
  • Other information (Regular Strength)

    each tablespoon (15mL) contains: magnesium 115mg, sodium 52mg
    store at up to 25°C (77°F); avoid freezing
    keep tightly closed
  • Other information (Extra Strength)

    each teaspoon (5mL) contains: magnesium 80mg, sodium 14mg
    store at up to 25°C (77°F); avoid freezing
    keep tightly closed
  • Inactive ingredients (Regular Strength)

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

  • Inactive ingredients (Extra Strength Cool Mint)

    benzyl alcohol, edetate disodium, flavor, glycerin, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, water, xanthan gum

  • Inactive Ingredients (Extra Strength Cherry)

    Benzyl alcohol, edentate disodium, flavor, glycerin, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, water, xanthan gum

  • Questions or comments?

    call toll-free (English/Spanish) 1-888-367-6471 weekdays

    Distributed by:

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Twp, PA 15108, Made in the U.S.A

    IMPORTANT:

    Do not use if foil inner seal imprinted "SEALED FOR YOUR PROTECTION" is disturbed or missing.

  • Principal Display Panel

    NDC 0135-0094-41

    Gaviscon®

    REGULAR STRENGTH

    LIQUID ANTACID

    Fast-Acting Heartburn Relief
    Helps Keep Acid Down for Hours

    COOL MINT

    FLAVOR

    12 fl oz (355 ml)

    ©2010 GlaxoSmithKline

    FRONT: 100631XB

    BACK: 100632XA

    Gaviscon Regular Strength 12 fl oz label
  • Principal Display Panel

    NDC 0135-0095-41

    Gaviscon®

    EXTRA STRENGTH

    LIQUID ANTACID

    Fast-Acting Heartburn Relief
    Helps Keep Acid Down for Hours

    COOL MINT

    FLAVOR

    12 fl oz (355 ml)

    ©2010 GlaxoSmithKline

    FRONT: 100651XB

    BACK: 100652XA

    Gaviscon Extra Strength 12 fl oz label
  • Principal Display Panel

    NDC 0135-0574-01

    Gaviscon®

    EXTRA STRENGTH

    LIQUID ANTACID

    Fast-Acting Heartburn Relief
    Helps Keep Acid Down for Hours

    CHERRY

    FLAVOR

    12 fl oz (355 ml)

    ©2014 GlaxoSmithKline

    FRONT: 103698XA

    BACK: 103699XA

    Gavison Extra Strength Cherry 12 fl oz (355mL) label
  • INGREDIENTS AND APPEARANCE
    GAVISCON 
    aluminum hydroxide and magnesium carbonate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0094
    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
    FlavorMINT (cool mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0094-41355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2011
    2NDC:0135-0094-42177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/14/2011
    GAVISCON 
    aluminum hydroxide and magnesium carbonate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0095
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE254 mg  in 5 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE237.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINT (cool mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0095-41355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/14/2011
    GAVISCON 
    aluminum hydroxide and magnesium carbonate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0574
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE254 mg  in 5 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE237.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0574-01355 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/01/2014
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)