Your browser does not support JavaScript! GAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]
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GAVISCON EXTRA STRENGTH (aluminum hydroxide and magnesium carbonate) tablet, chewable
GAVISCON REGULAR STRENGTH (aluminum hydroxide and magnesium trisilicate) tablet, chewable
[GlaxoSmithKline Consumer Healthcare LP]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

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

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

62187XB

Gaviscon Extra Strength Original flavor 100 count chewable tablets label

Principal Display Panel

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

62189XB

Gaviscon Extra Strength Cherry flavor 100 chewable tablets label

Principal Display Panel

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® and TORSO device® are registered trademarks of the GlaxoSmithKline group of companies.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Twp, PA 15108

©2009 GlaxoSmithKline

62188XA

Gaviscon Regular Strength 100 tablet label
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 Code GAVISCON
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0098-26100 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 Code GAVISCON
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0430-03100 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 TRISILICATE ANHYDROUS) 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 Code GAVISCON
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0096-26100 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: 02/2012
Document Id: bd3e240b-6705-4886-9d84-dee5a126e271
Set id: 7f367927-c366-465c-a059-e2cfb337d562
Version: 4
Effective Time: 20120221
 
GlaxoSmithKline Consumer Healthcare LP

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