Gaviscon Liquid
FDA Label NDC 0135-0574

18 label sections · Submitted to the FDA by Haleon Us Holdings Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Gaviscon (NDC 0135-0574). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 15 ml tablespoonful) regular strength, active ingredients (in each 5 ml / teaspoonful) extra strength, purposes, uses, ask a doctor or pharmacist before use if you, when using this product (regular strength), when using this product (extra strength), keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 15 Ml Tablespoonful) Regular Strength

Aluminum hydroxide 95 mg

Magnesium carbonate 358 mg

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

Aluminum hydroxide 254 mg

Magnesium carbonate 237.5 mg

Purposes

Antacid

Antacid

Uses

relieves

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

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.

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

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 (15 mL) contains:magnesium 115 mg, sodium 52 mg
  • store at up to 25°C (77°F). Avoid freezing.
  • keep tightly closed

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

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

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

Questions Or Comments?

1-800-452-0051

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

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

    HALEON

    Gaviscon

    LIQUID ANTACID

    EXTRA STRENGTH

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

      • COOL MINT
      FLAVOR

      12 FL OZ (355 mL)

      FRONT: 00213316

      BACK: 00213317

      HALEON

      Gaviscon

      LIQUID ANTACID

      EXTRA STRENGTH

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

        • CHERRY
        FLAVOR

        12 FL OZ (355 mL)

        FRONT: 00213320

        BACK: 00213322

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