FDA.reportPublic FDA data

Gaviscon

Manufacturer
Haleon US Holdings LLC
Effective date
2025-06-11
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:02:58

Label at a glance#

ProductGaviscon Extra Strength
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM CARBONATE
Label structure12 sections

Indications and uses

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

Dosage and administration

• chew 2-4 tablets four times a day or as directed by a doctor • take after meals and at bedtime or as needed • for best results follow by a half glass of water or other liquid • DO NOT SWALLOW WHOLE

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 160mg

Magnesium carbonate 105mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug. Antacids may interact with certain prescription drugs.
  • if you are on a sodium-restricted diet

When using this product

OTC - WHEN USING SECTION

  • do not take more than 16 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew 2-4 tablets four times a day or as directed by a doctor
  • take after meals and at bedtime or as needed
  • for best results follow by a half glass of water or other liquid
  • DO NOT SWALLOW WHOLE

Other information

SPL UNCLASSIFIED SECTION

  • Each tablet contains: magnesium 35mg, sodium 20mg
  • Store at up to 25°C (77°F) in a dry place

Inactive ingredients (Extra Strength)

INACTIVE INGREDIENT SECTION

alginic acid, calcium stearate, flavor, sodium bicarbonate, and sucrose. May contain stearic acid. Contains sorbitol or mannitol. May contain starch.

Inactive ingredients (Extra Strength Cherry)

INACTIVE INGREDIENT SECTION

acesulfame k, alginic acid, artificial flavor, calcium stearate, corn starch, corn syrup solids, mannitol, sodium bicarbonate, stearic acid, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-800-452-0051 (English/Spanish) weekdays

Generic Section

SPL UNCLASSIFIED SECTION

IMPORTANT: Do not use if foil inner seal printed “SEALED for YOUR PROTECTION” is disturbed or missing.

Principal Display Panel (Extra Strength Original Flavor)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gaviscon®

EXTRA STRENGTH

ANTACID

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

ORIGINAL FLAVOR

100 Chewable Tablets

Trademarks owned or licensed by Haleon.

Distributed by:

Haleon, Warren, NJ 07059

Made in France

©2024 Haleon or licensor.

215894 – Bottle Label

Gaviscon Extra Strength Tablet Original Flavor 100 ct
Gaviscon Extra Strength Tablet Original Flavor 100 ct

Principal Display Panel (Extra Strength Cherry Flavor)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gaviscon®

EXTRA STRENGTH

ANTACID

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

CHERRY FLAVOR

100 Chewable Tablets

Gaviscon Extra Strength Tablet Cherry 100 Ct
Gaviscon Extra Strength Tablet Cherry 100 Ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletPSN17
212978Gaviscon Extra Strength 160 MG / 105 MG Chewable TabletPSN17
212978aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable Tablet [Gaviscon]SBD17
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletSCD17
212978Gaviscon Extra Strength (aluminum hydroxide 160 MG / magnesium carbonate 105 MG) Chewable TabletSY17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0096-262025-02-01C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0098-262025-02-01C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0430-032025-02-01C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0098-262023-04-18C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0430-032023-04-18C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0096-262022-07-29C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0098-262022-07-29C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0430-032022-07-29C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0096-262020-11-18C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0098-262020-11-18C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0430-032020-11-18C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0096-262020-01-31C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0098-262020-01-31C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts
0135-0430-032020-01-31C16284748780-19d75b9d0-3fd9-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0098-26GavisconExtra Strength100 in 1 BOTTLETABLET, CHEWABLE10017
0135-0430-03GavisconExtra Strength100 in 1 BOTTLETABLET, CHEWABLE10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0098-26EA - Each0135-009898dfc34c-1e3e-43c6-89da-0be8440a0c6212012-07-24
0135-0430-03EA - Each0135-0430909107f4-1ed7-4afe-a965-cdc166c28a1c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN06
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NA6
MAGNESIUM TRISILICATEACTIVE INGREDIENTC2E1CI501T6
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN06
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D6
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8386
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G96
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZ6
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047L6
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6N6
MANNITOLINACTIVE INGREDIENT3OWL53L36A6
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO6
SORBITOLINACTIVE INGREDIENT506T60A25R6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP6
SUCROSEINACTIVE INGREDIENTC151H8M5546

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-00980135-0098-26
0135-04300135-0430-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
ALGINIC ACID8C3Z4148WZIACT
CALCIUM STEARATE776XM7047LIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SUCROSEC151H8M554IACT
STEARIC ACID4ELV7Z65APIACT
SORBITOL506T60A25RIACT
MANNITOL3OWL53L36AIACT
STARCH, CORNO8232NY3SJIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ALGINIC ACID8C3Z4148WZIACT
CALCIUM STEARATE776XM7047LIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
MANNITOL3OWL53L36AIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 72 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CORN SYRUPCORN SYRUP9G5L16BK6NSUSPENSION / ORAL2500 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSOLUTION / ORAL750 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTABLET / ORAL14.07 mgExact identifier — unii+route
36 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET, CHEWABLE / ORAL240 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALGINIC ACIDALGINIC ACID8C3Z4148WZTABLET, CHEWABLE / ORAL400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALGINIC ACIDALGINIC ACID8C3Z4148WZTABLET, CHEWABLE / ORAL400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, CHEWABLE / ORAL15 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSUSPENSION, EXTENDED RELEASE / ORAL1500 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, CHEWABLE / ORAL15 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSYRUP / ORAL600 mgExact identifier — unii+route
36 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NCAPSULE, EXTENDED RELEASE / ORAL28.5 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NCAPSULE, EXTENDED RELEASE / ORAL28.5 mgExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSYRUP / ORAL600 mgExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTROCHE / ORALNAExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSOLUTION / ORAL750 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTABLET, COATED / ORAL17 mgExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSOLUTION / ORAL750 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NELIXIR / ORAL400 mg/1mlExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTABLET, COATED / ORAL17 mgExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSUSPENSION / ORAL2500 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTABLET / ORAL14.07 mgExact identifier — unii+route
36 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALGINIC ACIDALGINIC ACID8C3Z4148WZTABLET, CHEWABLE / ORAL400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NCAPSULE, EXTENDED RELEASE / ORAL28.5 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTROCHE / ORALNAExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NCAPSULE, EXTENDED RELEASE / ORAL28.5 mgExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSOLUTION / ORAL750 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NELIXIR / ORAL400 mg/1mlExact identifier — unii+route
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, CHEWABLE / ORAL15 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTABLET / ORAL14.07 mgExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NELIXIR / ORAL400 mg/1mlExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSUSPENSION, EXTENDED RELEASE / ORAL1500 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
ALGINIC ACIDALGINIC ACID8C3Z4148WZTABLET, CHEWABLE / ORAL400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSUSPENSION, EXTENDED RELEASE / ORAL1500 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTROCHE / ORALNAExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NELIXIR / ORAL400 mg/1mlExact identifier — unii+route
36 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET, CHEWABLE / ORAL240 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSUSPENSION, EXTENDED RELEASE / ORAL1500 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTROCHE / ORALNAExact identifier — unii+route
36 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSYRUP / ORAL600 mgExact identifier — unii+route
36 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET, CHEWABLE / ORAL240 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NTABLET, COATED / ORAL17 mgExact identifier — unii+route
36 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gaviscon Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEHaleon US Holdings LLC7f367927-c366-465c-a059-e2cfb337d5622025-06-11WarningsExact identifier
ndc (package): 0135-0098-26
ndc (package): 0135-0430-03
ndc (product): 0135-0098
ndc (product): 0135-0430
ndc11 (package): 00135009826
ndc11 (package): 00135043003
spl id: 02f611d3-df31-4514-86ae-9e81004acdbf
spl set id: 7f367927-c366-465c-a059-e2cfb337d562

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.