Label: GAVISCON EXTRA STRENGTH- aluminum hydroxide and magnesium carbonate tablet, chewable
GAVISCON REGULAR STRENGTH- aluminum hydroxide and magnesium trisilicate tablet, chewable

  • NDC Code(s): 0135-0096-26, 0135-0098-26, 0135-0430-03
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

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 21, 2018

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

  • Active ingredients (in each tablet) (Extra Strength)

    Aluminum hydroxide 160mg

    Magnesium carbonate 105mg

  • Active ingredients (in each tablet) (Regular Strength)

    Dried aluminum hydroxide gel 80mg

    Magnesium trisilicate 14.2mg

  • Purpose

    Antacid

    Antacid

  • Uses (Extra Strength)

    relieves

    acid indigestion
    heartburn
    sour stomach
    upset stomach associated with these symptoms
  • Uses (Regular Strength)

    temporarily relieves symptoms of:

    heartburn and acid indigestion due to acid reflux
  • Warnings (Extra Strength)

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug. Antacids may interact with certain prescription drugs.
    if you are on a sodium-restricted diet

    When using this product

    do not take more than 16 tablets in 24 hours
    do not use the maximum dosage for more than 2 weeks

    Keep out of reach of children.

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

  • Warnings (Regular Strength)

    Do not use

    for peptic ulcers
    if you have trouble swallowing

    Ask a doctor before use if you have

    kidney disease
    a sodium restricted diet

    Ask a doctor or pharmacist if you

    are taking a prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if

    heartburn or stomach pain continues
    you need to take this product for more than 14 days

    Keep out of reach of children.

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

  • Directions (Extra Strength)

    chew 2-4 tablets four times a day or as directed by a doctor
    take after meals and at bedtime or as needed
    for best results follow by a half glass of water or other liquid
    DO NOT SWALLOW WHOLE
  • Directions (Regular Strength)

    do not swallow tablets whole
    chew 2 to 4 tablets after meals and at bedtime as needed (up to 4 times a day) or as directed by a doctor. For best results, drink a half glass of water or other liquid after each dose.
    do not take more than 16 tablets in 24 hours
  • Other information (Extra Strength)

    Each tablet contains: magnesium 35mg, sodium 20mg
    Store at up to 25°C (77°F) in a dry place
  • Other information (Regular Strength)

    Each tablet contains: magnesium 5mg, sodium 21 mg
    Store at up to 25°C (77°F) in a dry place
  • Inactive ingredients (Extra Strength)

    alginic acid, calcium stearate, flavor, sodium bicarbonate, and sucrose. May contain stearic acid. Contains sorbitol or mannitol. May contain starch.

  • Inactive ingredients (Extra Strength Cherry)

    acesulfame k, alginic acid, artificial flavor, calcium stearate, corn starch, corn syrup solids, mannitol, sodium bicarbonate, stearic acid, sucrose

  • Inactive ingredients (Regular Strength)

    alginic acid, calcium stearate, flavor, sodium bicarbonate, starch (may contain corn starch) and sucrose

  • Questions or comments?

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

  • Principal Display Panel

    NDC 0135-0098-26

    Gaviscon®

    EXTRA STRENGTH

    ANTACID

    Fast-Acting Heartburn Relief
    Helps Keep Acid Down for Hours

    ORIGINAL FLAVOR

    100 Chewable Tablets

    IMPORTANT: Do not use if foil inner seal printed "SEALED for YOUR PROTECTION" is disturbed or missing.

    GAVISCON® is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies and TORSO device is a registered trademark of the GlaxoSmithKline group of companies.

    Distributed by:

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Twp, PA 15108

    Made in France

    ©2012 GlaxoSmithKline

    102597XA

    Gavison Extra Strength 100 count label
  • Principal Display Panel

    NDC 0135-0430-03

    Gaviscon®

    EXTRA STRENGTH

    ANTACID

    Fast-Acting Heartburn Relief
    Helps Keep Acid Down for Hours

    CHERRY FLAVOR

    100 Chewable Tablets

    IMPORTANT: Do not use if foil inner seal printed "SEALED for YOUR PROTECTION" is disturbed or missing.

    GAVISCON® is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies and TORSO device is a registered trademark of the GlaxoSmithKline group of companies.

    Distributed by:

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Twp, PA 15108

    Made in France

    ©2012 GlaxoSmithKline

    102599XA

    Gavison Extra Strength Cherry 100 count label
  • Principal Display Panel

    NDC 0135-0096-26

    Gaviscon®

    REGULAR STRENGTH

    Alumina & Magnesium Trisilicate Tablets/ANTACID

    Relieves Heartburn Caused by Acid Reflux
    Unique Antacid Barrier

    ORIGINAL FLAVOR

    100 Chewable Tablets

    IMPORTANT: Do not use if foil inner seal printed "SEALED for YOUR PROTECTION" is disturbed or missing.

    GAVISCON® is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies and TORSO device is a registered trademark of the GlaxoSmithKline group of companies.

    Distributed by:

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Twp, PA 15108

    Made in France

    ©2012 GlaxoSmithKline

    102598XA

    Gavison Regular Strength 100 count label
  • INGREDIENTS AND APPEARANCE
    GAVISCON  EXTRA STRENGTH
    aluminum hydroxide and magnesium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0098
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE160 mg
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE105 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SUCROSE (UNII: C151H8M554)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITOL (UNII: 506T60A25R)  
    MANNITOL (UNII: 3OWL53L36A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorVANILLA (Vanilla Mint) Imprint Code GAVISCON
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0098-26100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/13/2011
    GAVISCON  EXTRA STRENGTH
    aluminum hydroxide and magnesium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0430
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE160 mg
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE105 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorCHERRYImprint Code GAVISCON
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0430-03100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/13/2011
    GAVISCON  REGULAR STRENGTH
    aluminum hydroxide and magnesium trisilicate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0096
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE80 mg
    MAGNESIUM TRISILICATE (UNII: C2E1CI501T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM TRISILICATE14.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorVANILLA (Vanilla Mint) Imprint Code GAVISCON
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0096-26100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01868506/13/2011
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)