Active Ingredient (Per Tablet)
Calcium Carbonate USP 500 mg
Regular Strength Tablet, Chewable
FDA Label NDC 68163-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Regular Strength (NDC 68163-100). 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 (per tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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
- acid indigestion,
- sour stomach
- upset stomach associated with these symptoms
Warnings
Ask a doctor before use if you are taking prescription drugs. 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
- adults and children 12 years of age and over: chew 2-4 tablets completely 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.
Other Information
- each tablet contains: elemental calcium 200 mg
- store at room temperature. Keep the container tightly closed
Inactive Ingredients
Adipic acid, dextrose, FD&C Red No. 40, FD & C Yellow No. 6, flavor, magnesium stearate, maltodextrin, starch, sucralose.
Questions Or Comments
1-866-467-2748
Principal Display Panel
DRx CHOICE®
NDC# 68163-100-66
*Compare to the active ingredient in Regular Strength Tums®
REGULAR STRENGTH
Antacid Tablets
Calcium Carbonate 500 mg
Fast Relief of Upset Stomach, Heartburn and Acid Indigestion
Tropical Fruit
Naturally and Artificially Flavored
66 Chewable Tablets
GLUTEN-FREE
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Regular Strength Tums®
* Please review the disclaimer below.
