Extra Strength Smooth Tablet, Chewable
FDA Label NDC 21130-515

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 21130-515). 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

Active Ingredient (Per Tablet)

Calcium Carbonate USP 750mg

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: 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# 21130-515-60

*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 Berries

Naturally and Artificially Flavored

60 Chewable Tablets

K PAREVE

GLUTEN- FREE

Distributed by:

*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)

Extras Strength Smooth Antacid Calcium Carbonate Assorted Berry (103af72pvlflb)

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