Active Ingredient (Per Tablet)
Calcium Carbonate USP 750mg
Pv Extra Strength Smooth
FDA Label NDC 68016-695
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Pv Extra Strength Smooth (NDC 68016-695). 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?, 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 completely as symptoms occur, or as directed by a doctor. Do not swallow the 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 Lake, FD&C Red No. 40 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.
Questions?
1-866-467-2748
Safety sealed: Do not use if printed seal under cap is torn or missing
Package/Label Principal Display Panel
NDC# 68016-695-60
Compare to the active ingredient in Extra Strength Tums® Smoothies™
EXTRA STRENGTH
Smooth Antacid Tablets
Calcium Carbonate USP 750 mg
Fas Relief of Upset Stomach, Heartburn and Acid Indigestion
ASSORTED BERRY
Naturally and Artificially Flavored
60 Chewable Tablets
K PAREVE
GLUTEN- FREE
Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
*This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Extra Strength Tums® Smoothies™.
Extras Strength Smooth Antacid Calcium Carbonate Assorted Berry (103af72pvlflb)
* Please review the disclaimer below.
