GAVISCON- aluminum hydroxide and magnesium carbonate liquid

GAVISCON by

Drug Labeling and Warnings

GAVISCON by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

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

INGREDIENTS AND APPEARANCE

GAVISCON 
aluminum hydroxide and magnesium carbonate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0094
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	95 mg  in 15 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	358 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN	Score
Shape		Size
Flavor	MINT (cool mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0094-41	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2011
2	NDC: 0135-0094-42	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	01/14/2011

GAVISCON 
aluminum hydroxide and magnesium carbonate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0095
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	254 mg  in 5 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	237.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN	Score
Shape		Size
Flavor	MINT (cool mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0095-41	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	01/14/2011

GAVISCON 
aluminum hydroxide and magnesium carbonate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0574
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	254 mg  in 5 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	237.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0574-01	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	08/01/2014

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)