Active Ingredient
Calcium Carbonate USP 750mg
Extra Strength Smooth Tablet, Chewable
FDA Label NDC 21130-516
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Extra Strength Smooth (NDC 21130-516). 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 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 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: calcium 300mg
• Store at room temperature. Keep the container tightly closed
Inactive Ingredients
adipic acid, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Red No. 40 Lake, FD&C Yellow No. 6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose
Safety sealed: Do not use if printed seal under cap is torn or missing
Package/Label Principal Display Panel
*Compare to the active ingredient in Extra Strength Tums® Smoothies™
EXTRA STRENGTH
Smooth Antacid Tablets
Calcium Carbonate 750 mg
Assorted Fruit
Naturally and Artificially Flavored
For Fast Relief of Heartburn, Acid Indigestion & Upset Stomach
60 Chewable Tablets
Distributed by:
*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark, Extra Strength Tums® Smoothies™
Extra Strength Smooth Antacid Tablets Assorted Fruit (115af90lflb)
* Please review the disclaimer below.
