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Acid Gone Antacid

Extra Strength Acid Gone Antacid 100 Chewable Tablets Drug Facts

Approved
Approval ID

4498104a-e41d-41d9-9aed-01904d91af87

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Major Pharmaceuticals

DUNS: 191427277

Products 1

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 Code0904-5365
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide and magnesium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (8)

ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

Principal Display Panel

NDC 0904-5365-60

EXTRA STRENGTH

Acid Gone™

Antacid

STOPS HEARTBURN

QUICK ACTION

LONG LASTING

COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH GAVISCON ®*

100 CHEWABLE TABLETS

Distributed by:

MAJOR**®**PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48150, USA

*This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Extra Strength Gaviscon ®

Major Extra Strength Acid Gone Antacid 100ct

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/19/2025

Uses

relieves

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/19/2025

Inactive ingredients

alginic acid, calcium stearate, compressible sugar, flavor, sodium bicarbonate, starch(corn), sucrose.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/19/2025

Questions or comments?

call 1-800-616-2471

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/19/2025

Active ingredients (in each tablet)

Aluminum hydroxide 160mg

Magnesium carbonate 105mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/19/2025

Purpose

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 9/19/2025

Warnings

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

  • 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.

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/19/2025

Directions

  • 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 TABLET WHOLE

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/19/2025

Other information

  • Each tablet contains**:**sodium 19 mg, magnesium 31mg
  • Store at room temperature

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Acid Gone Antacid - FDA Drug Approval Details