FDA Product

Gaviscon Regular Strength

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Gaviscon Regular Strength

FDA Product Code

0135-0096

Regulatory Information

NDC Product Code

0135-0096

Application Number

M001

Marketing Category

C200263

Effective Date

May 15, 2025

Territorial Authority

USA

FDA Title

Drug Facts

Labeling Type

HUMAN OTC DRUG LABEL

Version Number

16

Company Information

ManufacturerHaleon US Holdings LLC

DUNS Number

079944263

Active Ingredients

ALGINIC ACID

Code: 8C3Z4148WZ

Class Code: IACT

CALCIUM STEARATE

Code: 776XM7047L

Class Code: IACT

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

ALUMINUM HYDROXIDE

Quantity: 80 mg in 1 1

Code: 5QB0T2IUN0

Class Code: ACTIB

MAGNESIUM TRISILICATE

Quantity: 14.2 mg in 1 1

Code: C2E1CI501T

Class Code: ACTIB

Active Moieties

ALUMINUM HYDROXIDE

Code: 5QB0T2IUN0

MAGNESIUM CATION

Code: T6V3LHY838

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