Ultra Strength Antacid
FDA Label NDC 68163-316

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 Ultra Strength Antacid (NDC 68163-316). 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

Active Ingredient (Per Tablet)

Calcium Carbonate USP 1000 mg

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 presentlytaking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 7 tablets in 24 hours
  • if pregnant do not take more than 5 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 2-3 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets as whole.
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other Information

  • each tablet contains: calcium 400 mg
  • store at room temperature. Keep the container tightly closed

Inactive Ingredients

adipic acid, D&C red No. 27 Lake, D&C yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C yellow No. 6 Lake, 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

DRx CHOICE

Compare to the active ingredient in Ultra Strength TUMS®

ULTRA STRENGTH

Antacid Tablets

Calcium Carbonate 1000mg

Fast Relief of Upset stomach, Heartburn and Acid Indigestion

Assorted Fruit

Naturally &Artificially Flavored

GLUTEN-FREE

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

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court

East Brunswick, NJ 08816

Package label for 160 Chewable Tablets

Drx Choice Ultra Strength Antacid 160 Chewable Tablets (102ab96pvlflb)

Drx Choice Ultra Strength Antacid 160 Chewable Tablets (102ab96pvlflb)

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