Ultra Strength Antacid Assorted Berries Tablet, Chewable
FDA Label NDC 53041-161

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guardian Drug Company for the product Ultra Strength Antacid Assorted Berries (NDC 53041-161). 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/breastfeeding,, 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 1000 mg

Purpose

Antacid

Use(S)

relieves:

  • acid indigestion
  • heartburn

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 7 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/Breastfeeding,

ask a health professional before use.

Keep Out Of Reach Of Children

.

Directions

  • adults and children 12 years of age and over: wet in mouth before chewing, chew 2-3 tablets as symptoms occur, or as directed by a doctor.

Other Information

  • each tablet contains: elemental calcium 400 mg
  • do not use if printed seal under the cap is torn or missing
  • store at room temperature. keep the container tightly closed.

Inactive Ingredients

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

Principal Display Panel

Compare to the active ingredient in Tums® Ultra Strength*


GUARDIAN 


NDC 53041-161-68 


Ultra Strength

Alkums

Antacid Tablets

Assorted Berry Flavors

Calcium Carbonate 1000 mg


Relieves:

  • Acid Indigestion
  • Heartburn and 

    • 72 CHEWABLE TABLETS


    171ab-72-gdc.jpg (171ab 72 Gdc)

    171ab-72-gdc.jpg (171ab 72 Gdc)

      


* Please review the disclaimer below.