Drug Facts

Drug Facts
SPL v23
SPL
SPL Set ID 2d74e5bc-1f10-4fb6-9258-cd906e360013
Route
ORAL
Published
Effective Date 2025-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (95 mg) Carbonate Ion (358 mg)
Inactive Ingredients
Benzyl Alcohol Edetate Disodium Glycerin Water Sodium Alginate Saccharin Sodium Sorbitol Xanthan Gum Dimethicone, Unspecified

Identifiers & Packaging

Pill Appearance
Color: green Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-08-01

Description

Aluminum hydroxide 95 mg Magnesium carbonate 358 mg

Purpose

Antacid Antacid


Medication Information

Purpose

Antacid Antacid

Description

Aluminum hydroxide 95 mg Magnesium carbonate 358 mg

Uses

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Purposes

Antacid

Antacid

Additional Information

Do not use if printed inner safety seal under cap is broken or missing.

Trademarks are owned by or licensed to the Haleon group of companies.

©2025 Haleon group of companies or its licensor.

Pat. Info www.productpats.com

Distributed by:

Haleon

Warren, NJ 07059

Made in Mexico

Questions Or Comments?

1-800-452-0051

Principal Display Panel

NDC 0135-0094-41

Gaviscon

LIQUID ANTACID

REGULAR STRENGTH

  • Fast-Acting Heartburn Relief
  • Helps Keep Acid Down for Hours

COOL MINT

FLAVOR

12 FL OZ (355 mL)

FRONT: 00067473

BACK: 00067474

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
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
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information (extra Strength)
  • each teaspoon (5 mL) contains:magnesium 75 mg, sodium 11 mg
  • store at up to 25°C (77°F). Avoid freezing.
  • keep tightly closed
Other Information (regular Strength)
  • each tablespoon (15 mL) contains:magnesium 115 mg, sodium 52 mg
  • 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

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
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 except under the advice and supervision of a doctor
  • laxative effect may occur
Ask A Doctor Or Pharmacist Before Use If You
  • have kidney disease
  • are on a sodium-restricted diet or a magnesium-restricted diet
  • are taking a prescription drug. Antacids may interact with certain prescription drugs.
Inactive Ingredients (extra Strength Cherry)

benzyl alcohol, edetate disodium, glycerin, natural and artificial flavors, purified water, simethicone emulsion, sodium alginate, sodium saccharin, sorbitol solution, xanthan gum

Inactive Ingredients (extra Strength Cool Mint)

benzyl alcohol, edetate disodium, glycerin, natural and artificial flavors, purified water, simethicone emulsion, sodium alginate, sodium saccharin, sorbitol solution, xanthan gum

Active Ingredients (in Each 5 Ml / Teaspoonful) Extra Strength

Aluminum hydroxide 254 mg

Magnesium carbonate 237.5 mg

Active Ingredients (in Each 15 Ml Tablespoonful) Regular Strength

Aluminum hydroxide 95 mg

Magnesium carbonate 358 mg


Structured Label Content

Uses

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Purposes

Antacid

Antacid

Additional Information

Do not use if printed inner safety seal under cap is broken or missing.

Trademarks are owned by or licensed to the Haleon group of companies.

©2025 Haleon group of companies or its licensor.

Pat. Info www.productpats.com

Distributed by:

Haleon

Warren, NJ 07059

Made in Mexico

Questions Or Comments? (Questions or comments?)

1-800-452-0051

Principal Display Panel

NDC 0135-0094-41

Gaviscon

LIQUID ANTACID

REGULAR STRENGTH

  • Fast-Acting Heartburn Relief
  • Helps Keep Acid Down for Hours

COOL MINT

FLAVOR

12 FL OZ (355 mL)

FRONT: 00067473

BACK: 00067474

Directions (extra Strength) (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
Directions (regular Strength) (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
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information (extra Strength) (Other information (Extra Strength))
  • each teaspoon (5 mL) contains:magnesium 75 mg, sodium 11 mg
  • store at up to 25°C (77°F). Avoid freezing.
  • keep tightly closed
Other Information (regular Strength) (Other information (Regular Strength))
  • each tablespoon (15 mL) contains:magnesium 115 mg, sodium 52 mg
  • store at up to 25°C (77°F). Avoid freezing.
  • keep tightly closed
Inactive Ingredients (regular Strength) (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

When Using This Product (extra Strength) (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
When Using This Product (regular Strength) (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 except under the advice and supervision of a doctor
  • laxative effect may occur
Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)
  • have kidney disease
  • are on a sodium-restricted diet or a magnesium-restricted diet
  • are taking a prescription drug. Antacids may interact with certain prescription drugs.
Inactive Ingredients (extra Strength Cherry) (Inactive ingredients (Extra Strength Cherry))

benzyl alcohol, edetate disodium, glycerin, natural and artificial flavors, purified water, simethicone emulsion, sodium alginate, sodium saccharin, sorbitol solution, xanthan gum

Inactive Ingredients (extra Strength Cool Mint) (Inactive ingredients (Extra Strength Cool Mint))

benzyl alcohol, edetate disodium, glycerin, natural and artificial flavors, purified water, simethicone emulsion, sodium alginate, sodium saccharin, sorbitol solution, xanthan gum

Active Ingredients (in Each 5 Ml / Teaspoonful) Extra Strength (Active ingredients (in each 5 mL / teaspoonful) Extra Strength)

Aluminum hydroxide 254 mg

Magnesium carbonate 237.5 mg

Active Ingredients (in Each 15 Ml Tablespoonful) Regular Strength (Active ingredients (in each 15 mL tablespoonful) Regular Strength)

Aluminum hydroxide 95 mg

Magnesium carbonate 358 mg


Advanced Ingredient Data


Raw Label Data

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