Active Ingredient
Calcium carbonate USP 500mg
Major Regular Strength Tablet, Chewable
FDA Label NDC 0904-6412
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Major Regular Strength (NDC 0904-6412). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
relieves:
• heartburn
• sour stomach
• acid indigestion
• upset stomach associated with these symptoms
Warnings
Ask a doctor or pharmacist before use if you are 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
• do not use the maximum dosage for more than 2 weeks.
Directions
• Chew 2-4 tablets as symptoms occur, or as directed by a doctor.
Other Information
• Store below 30°C (86°F).
• Keep the container tightly closed
• For calcium and magnesium content see Supplement Facts.
Inactive Ingredients
adipic acid, blue 1 aluminum lake, dextrose, flavors, magnesium stearate, maltodextrin, red 27 aluminum lake, starch, sucralose, yellow 6 aluminum lake, yellow 10 aluminum lake.
CALCIUM SUPPLEMENT
USES: As a daily source of extra calcium.
DIRECTIONS: Chew 2 tablets once or twice daily with a meal
Supplement Facts
Serving Size: 2 Tablets
Servings Per Container: 75
Amount Per Serving % | Daily Value |
Calories 5 | |
Sugars 1.5g | |
Calcium 400mg | 40% |
Magnesium 2mg | less than 1% |
Package/Label Principal Display Panel
Compare to active ingredient in Tums*
Major
Calcium
Antacid Tablets
Regular Strength
Assorted Flavors
Antacid/Calcium Supplement
Calcium Carbonate 500mg
150 Chewable Tablets
Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia MI 48150
* Please review the disclaimer below.
