Major Regular Strength Assorted Flavors

ANTACID TABLETS ORAL HUMAN OTC DRUG

Major Regular Strength Assorted Flavors is an FDA drug label for the active ingredient ANTACID TABLETS manufactured by Major Pharmaceuticals administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260713.

Generic name
ANTACID TABLETS
Manufacturer
Major Pharmaceuticals
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
0904-6412
Application
M001
Label effective
20260713

About this product

Major Regular Strength Assorted Flavors is an FDA-registered drug product whose active ingredient is ANTACID TABLETS. It is labelled by Major Pharmaceuticals taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0904-6412, application M001, label effective 20260713. It is one of 9 FDA drug label records sharing the active ingredient ANTACID TABLETS. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing ANTACID TABLETS are most often described in connection with: relieves heartburn, sour stomach, acid indigestion. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Calcium Carbonate USP 500mg

Indications & Usage

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

Dosage & Administration

Directions • Adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor. • Do not swallow tablets whole, • Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

Warnings

Warnings Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product • do not take more than 15 tablets in 24 hours • If pregnant do not take more than 10 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

More products with the same ingredient

ANTACID TABLETS

CVS PHARMACY,INC. Assorted Berry

CVS PHARMACY,INC. View label

CVS PHARMACY,INC. Assorted Fruit

CVS PHARMACY,INC. View label

CVS Ultra Strength

CVS View label

Extra Strength

CVS PHARMACY View label

Extra Strength Smooth

CVS View label

Ultra Strength Antacid

THE KROGER CO., View label

WHOLE FOODS MARKET Health Ultra Strength Natural Antacid Peppermint Flavor

WHOLE FOODS MARKET, INC. View label

How products containing ANTACID TABLETS compare

FDA lists 9 drug label records with ANTACID TABLETS as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — CVS 2
— — CVS PHARMACY,INC. 2
— — CVS PHARMACY 1
— — Major Pharmaceuticals 1
— — THE KROGER CO., 1

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0702-2026 Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61 Major Pharmaceuticals Class II Ongoing 20260729
D-0709-2026 Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61 Major Pharmaceuticals Class II Ongoing 20260729
D-0711-2026 Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61 Major Pharmaceuticals Class II Ongoing 20260729
D-0703-2026 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61 Major Pharmaceuticals Class II Ongoing 20260729
D-0710-2026 Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61 Major Pharmaceuticals Class II Ongoing 20260729

Frequently asked questions

What is Major Regular Strength Assorted Flavors used for?
Uses relieves: • heartburn • sour stomach • acid indigestion • upset stomach associated with these symptoms

Who makes Major Regular Strength Assorted Flavors?
Major Pharmaceuticals is the labeler of record for Major Regular Strength Assorted Flavors. 9 FDA label records share the active ingredient ANTACID TABLETS, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Major Regular Strength Assorted Flavors come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Major Regular Strength Assorted Flavors prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ANTACID TABLETS?
Yes. 9 FDA drug label records list ANTACID TABLETS as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Major Regular Strength Assorted Flavors been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.