Premier Value Chewable Antacid Tablet, Chewable
FDA Label NDC 68016-652

8 label sections · Submitted to the FDA by Chain Drug Consortium, Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Premier Value Chewable Antacid (NDC 68016-652). 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

Active Ingredient

Calcium Carbonate USP 500mg

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 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 tablets contains: elemental calcium 200mg

• store at room temperature. Keep the container tightly closed

Inactive Ingredients

adipic acid, D&C Red No. 27, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, FD&C Yellow No. 6, flavor, magnesium stearate, maltodextrin, starch, sucralose

Package/Label Principal Display Panel

*Compare to the active ingredient in Regular Strength Tums®

Premier Value®

REGULAR STRENGTH

Antacid Tablets

CALCIUM CARBONATE USP 500mg

For Fast Relief of Heartburn, Acid Indigestion & Upset Stomach

ASSORTED FRUIT

Naturally and Artificially Flavored

150 Chewable Tablets

Distributed by

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Regular Strength of Tums®

Premier Value Regular Strength Assorted Fruit Antacid Tablets (101af150pvlflb)

Premier Value Regular Strength Assorted Fruit Antacid Tablets (101af150pvlflb)

Premier Value Regular Strength Assorted Fruit Antacid Tablets

* Please review the disclaimer below.