GAVISCON

Dosage form: liquid
Ingredients: ALUMINUM HYDROXIDE 95mg in 15mL, MAGNESIUM CARBONATE 358mg in 15mL
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0094

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 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

GAVISCON 
aluminum hydroxide and magnesium carbonate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0094
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE95 mg  in 15 mL
MAGNESIUM CARBONATE (CARBONATE ION) MAGNESIUM CARBONATE358 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
D&C YELLOW NO. 10 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
GLYCERIN 
SACCHARIN SODIUM 
SODIUM ALGINATE 
SORBITOL 
WATER 
XANTHAN GUM 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (cool mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0094-41355 mL in 1 BOTTLE
2NDC:0135-0094-42177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/14/2011
GAVISCON 
aluminum hydroxide and magnesium carbonate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0095
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE254 mg  in 5 mL
MAGNESIUM CARBONATE (CARBONATE ION) MAGNESIUM CARBONATE237.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
EDETATE DISODIUM 
GLYCERIN 
SACCHARIN SODIUM 
DIMETHICONE 
SILICON DIOXIDE 
SODIUM ALGINATE 
SORBITOL 
WATER 
XANTHAN GUM 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (cool mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0095-41355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/14/2011
GAVISCON 
aluminum hydroxide and magnesium carbonate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0574
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE254 mg  in 5 mL
MAGNESIUM CARBONATE (CARBONATE ION) MAGNESIUM CARBONATE237.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
EDETATE DISODIUM 
GLYCERIN 
SACCHARIN SODIUM 
DIMETHICONE 
SILICON DIOXIDE 
SODIUM ALGINATE 
SORBITOL 
WATER 
XANTHAN GUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0574-01355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33108/01/2014
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 07/2014
 
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.

Hide
(web3)