Gaviscon Liquid
FDA Label NDC 0135-0095

Full FDA labeling including 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 0135-0095). 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 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., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

    • COOL MINT

    FLAVOR

    12 fl oz (355 ml)

    ©2010 GlaxoSmithKline

    FRONT: 100631XB

    BACK: 100632XA

    Gaviscon Regular Strength 12 Fl Oz Label (E89689fb F0c5 49c6 A957 D378cd039742 01)

    Gaviscon Regular Strength 12 Fl Oz Label (E89689fb F0c5 49c6 A957 D378cd039742 01)

    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

      Gaviscon Extra Strength 12 Fl Oz Label (E89689fb F0c5 49c6 A957 D378cd039742 02)

      Gaviscon Extra Strength 12 Fl Oz Label (E89689fb F0c5 49c6 A957 D378cd039742 02)

      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

        Gavison Extra Strength Cherry 12 Fl Oz (355ml) Label (E89689fb F0c5 49c6 A957 D378cd039742 03)

        Gavison Extra Strength Cherry 12 Fl Oz (355ml) Label (E89689fb F0c5 49c6 A957 D378cd039742 03)

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