FDA Label for Gaviscon
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 15ML TABLESPOONFUL) REGULAR STRENGTH
- ACTIVE INGREDIENT (IN EACH 5ML TEASPOONFUL) EXTRA STRENGTH
- PURPOSE
- USES
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT (REGULAR STRENGTH)
- WHEN USING THIS PRODUCT (EXTRA STRENGTH)
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS (REGULAR STRENGTH)
- DIRECTIONS (EXTRA STRENGTH)
- OTHER INFORMATION (REGULAR STRENGTH)
- OTHER INFORMATION (EXTRA STRENGTH)
- INACTIVE INGREDIENTS (REGULAR STRENGTH)
- INACTIVE INGREDIENTS (EXTRA STRENGTH COOL MINT)
- INACTIVE INGREDIENTS (EXTRA STRENGTH CHERRY)
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Gaviscon Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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• Fast-Acting Heartburn Relief• Helps Keep Acid Down for Hours• Fast-Acting Heartburn Relief• Helps Keep Acid Down for Hours
COOL MINT
FLAVOR
12 fl oz (355 ml)
©2010 GlaxoSmithKline
FRONT: 100631XB
BACK: 100632XA
NDC 0135-0095-41
Gaviscon®
EXTRA STRENGTH
LIQUID ANTACID
COOL MINT
FLAVOR
12 fl oz (355 ml)
©2010 GlaxoSmithKline
FRONT: 100651XB
BACK: 100652XA
NDC 0135-0574-01
Gaviscon®
EXTRA STRENGTH
LIQUID ANTACID
CHERRY
FLAVOR
12 fl oz (355 ml)
©2014 GlaxoSmithKline
FRONT: 103698XA
BACK: 103699XA
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