GAVISCON EXTRA STRENGTH - aluminum hydroxide and magnesium carbonate tablet, chewable
GAVISCON REGULAR STRENGTH - aluminum hydroxide and magnesium trisilicate tablet, chewable
GlaxoSmithKline Consumer Healthcare LP

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.

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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

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

62187XB

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.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Twp, PA 15108

Made in France

62189XB

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

62188XA

Gaviscon Regular Strength 100 tablet label

GAVISCON EXTRA STRENGTH
aluminum hydroxide and magnesium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0098
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE)	ALUMINUM HYDROXIDE	160 mg
MAGNESIUM CARBONATE (CARBONATE ION)	MAGNESIUM CARBONATE	105 mg

Inactive Ingredients
Ingredient Name	Strength
ALGINIC ACID
CALCIUM STEARATE
SODIUM BICARBONATE
SUCROSE
STEARIC ACID
SORBITOL
MANNITOL
STARCH, CORN

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor	VANILLA (Vanilla Mint)	Imprint Code	GAVISCON
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0135-0098-26	100 TABLET, CHEWABLE in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	06/13/2011

GAVISCON EXTRA STRENGTH
aluminum hydroxide and magnesium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0430
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE)	ALUMINUM HYDROXIDE	160 mg
MAGNESIUM CARBONATE (CARBONATE ION)	MAGNESIUM CARBONATE	105 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM
ALGINIC ACID
CALCIUM STEARATE
STARCH, CORN
CORN SYRUP
MANNITOL
SODIUM BICARBONATE
STEARIC ACID
SUCROSE

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor	CHERRY	Imprint Code	GAVISCON
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0135-0430-03	100 TABLET, CHEWABLE in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	06/13/2011

GAVISCON REGULAR STRENGTH
aluminum hydroxide and magnesium trisilicate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0096
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE)	ALUMINUM HYDROXIDE	80 mg
MAGNESIUM TRISILICATE (MAGNESIUM TRISILICATE ANHYDROUS)	MAGNESIUM TRISILICATE	14.2 mg

Inactive Ingredients
Ingredient Name	Strength
ALGINIC ACID
CALCIUM STEARATE
SODIUM BICARBONATE
STARCH, CORN
SUCROSE

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor	VANILLA (Vanilla Mint)	Imprint Code	GAVISCON
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0135-0096-26	100 TABLET, CHEWABLE in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018685	06/13/2011

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 01/2012 GlaxoSmithKline Consumer Healthcare LP