Gaviscon Extra Strength

Dosage form: tablet, chewable
Ingredients: ALUMINUM HYDROXIDE 160mg, MAGNESIUM CARBONATE 105mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0098

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 Facts

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

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

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

GAVISCON  EXTRA STRENGTH
aluminum hydroxide and magnesium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0098
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE160 mg
MAGNESIUM CARBONATE (CARBONATE ION) MAGNESIUM CARBONATE105 mg
Inactive Ingredients
Ingredient NameStrength
ALGINIC ACID 
CALCIUM STEARATE 
SODIUM BICARBONATE 
SUCROSE 
STEARIC ACID 
SORBITOL 
MANNITOL 
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorVANILLA (Vanilla Mint) Imprint CodeGAVISCON
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0098-26100 TABLET, CHEWABLE in 1 BOTTLE
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE160 mg
MAGNESIUM CARBONATE (CARBONATE ION) MAGNESIUM CARBONATE105 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ALGINIC ACID 
CALCIUM STEARATE 
STARCH, CORN 
CORN SYRUP 
MANNITOL 
SODIUM BICARBONATE 
STEARIC ACID 
SUCROSE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorCHERRYImprint CodeGAVISCON
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0430-03100 TABLET, CHEWABLE in 1 BOTTLE
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE80 mg
MAGNESIUM TRISILICATE (MAGNESIUM CATION) MAGNESIUM TRISILICATE14.2 mg
Inactive Ingredients
Ingredient NameStrength
ALGINIC ACID 
CALCIUM STEARATE 
SODIUM BICARBONATE 
STARCH, CORN 
SUCROSE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorVANILLA (Vanilla Mint) Imprint CodeGAVISCON
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0096-26100 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01868506/13/2011
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 08/2014
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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