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Gaviscon

Drug Facts

Approved
Approval ID

7f367927-c366-465c-a059-e2cfb337d562

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

Haleon US Holdings LLC

DUNS: 079944263

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

aluminum hydroxide and magnesium carbonate

PRODUCT DETAILS

NDC Product Code0135-0098
Application NumberM001
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 15, 2025
Generic Namealuminum hydroxide and magnesium carbonate

INGREDIENTS (10)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 160 mg in 1 1
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM CARBONATEActive
Quantity: 105 mg in 1 1
Code: 0E53J927NA
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT

aluminum hydroxide and magnesium carbonate

PRODUCT DETAILS

NDC Product Code0135-0430
Application NumberM001
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 15, 2025
Generic Namealuminum hydroxide and magnesium carbonate

INGREDIENTS (11)

ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 160 mg in 1 1
Code: 5QB0T2IUN0
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MAGNESIUM CARBONATEActive
Quantity: 105 mg in 1 1
Code: 0E53J927NA
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT

aluminum hydroxide and magnesium trisilicate

PRODUCT DETAILS

NDC Product Code0135-0096
Application NumberM001
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 15, 2025
Generic Namealuminum hydroxide and magnesium trisilicate

INGREDIENTS (7)

ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 80 mg in 1 1
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM TRISILICATEActive
Quantity: 14.2 mg in 1 1
Code: C2E1CI501T
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/15/2025

Principal Display Panel

NDC 0135-0096-26

Gaviscon®

REGULAR STRENGTH

Alumina & Magnesium Trisilicate Tablets/ANTACID

  • Relieves Heartburn Caused by Acid Reflux
  • Unique Antacid Barrier

ORIGINAL FLAVOR

100 Chewable Tablets

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

GAVISCON® is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies and TORSO device is a registered trademark of the GlaxoSmithKline group of companies.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Twp, PA 15108

Made in France

©2012 GlaxoSmithKline

102598XA

Gaviscon Regular Strength Tablets Original 100 ct.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/10/2013

Uses (Regular Strength)

temporarily relieves symptoms of:

  • heartburn and acid indigestion due to acid reflux

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/10/2013

Active ingredients (in each tablet) (Regular Strength)

Dried aluminum hydroxide gel 80mg

Magnesium trisilicate 14.2mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/10/2013

Purpose

Antacid

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 10/10/2013

Warnings (Regular Strength)

Do not use

  • for peptic ulcers
  • if you have trouble swallowing

Ask a doctor before use if you have

  • kidney disease
  • a sodium restricted diet

Ask a doctor or pharmacist if you

  • are taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

  • heartburn or stomach pain continues
  • you need to take this product for more than 14 days

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/10/2013

Directions (Regular Strength)

*do not swallow tablets whole

  • chew 2 to 4 tablets after meals and at bedtime as needed (up to 4 times a day) or as directed by a doctor. For best results, drink a half glass of water or other liquid after each dose.
  • do not take more than 16 tablets in 24 hours

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/14/2025

Generic Section

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/10/2013

Inactive ingredients (Regular Strength)

alginic acid, calcium stearate, flavor, sodium bicarbonate, starch (may contain corn starch) and sucrose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/14/2025

Questions or comments?

call toll-free1-800-452-0051(English/Spanish) weekdays

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Gaviscon - FDA Drug Approval Details