MedPath

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0135-0098
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide and magnesium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2025
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0135-0430
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide and magnesium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2025
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0135-0096
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide and magnesium trisilicate
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2025
FDA Product Classification

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