Active Ingredient (Per Tablet)
Calcium Carbonate USP 750mg
Extra Strength Antacid Tablet, Chewable
FDA Label NDC 68163-102
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 Extra Strength Antacid (NDC 68163-102). 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, directions, other information, inactive ingredients, questions or comments?, 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 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 10 tablets in 24 hours
- If pregnant do not take more than 6 tablets in 24 hours
- do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
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
Other Information
• each tablet contains: elemental calcium 300mg
• store at room temperature. Keep the container tightly closed.
Inactive Ingredients
adipic acid, dextrose, FD&C Blue No. 1, FD&C Red No. 40, flavors, magnesium stearate, maltodextrin, starch, sucralose.
Questions Or Comments?
1-866-467-2748
SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Package/Label Principal Display Panel
NDC 68163-102-24
*Compare to the active ingredient in Extra Strength Tums®
EXTRA STRENGTH
Antacid Tablets
Calcium Carbonate Tablets 750 mg
Fast Relief of Upset Stomach, Heartburn and Acid Indigestion
Assorted Berries
Naturally & Artificially Flavored
96 Chewable Tablets
K PARVE
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, Extra Strength Tums®.
Extra Strength Antacid Calcium Carbonate 750 mg (102ab96pvlflb)
* Please review the disclaimer below.
