Extra Strength Smooth Antacid
FDA Label NDC 71713-204

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Thirty Madison Inc for the product Extra Strength Smooth Antacid (NDC 71713-204). 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 (in each tablet), purpose, use(s), warnings, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast feeding,, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Calcium carbonate 750 mg

Purpose

Antacid

Use(S)

relieves:

  • acid indigestion
  • heartburn
  • 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 a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children

.

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 take for symptoms that persists for more than 2 weeks unless advised by a doctor.

Other Information

  • each tablet contains: elemental calcium 300 mg
  • store at room temperature. keep the container tightly closed.

Inactive Ingredients

adipic acid, corn starch, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose, talc.

Principal Display Panel

Extra Strength
Smooth
Antacid Tablets
evens
Chill Berries 
Calcium Carbonate 750 mg

60 Chewable Tablets

Compare to the active ingredient  in TUMS®SmoothiesTM EX



173 (173bf)

173 (173bf)



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