Extra Strength Antacid Tropical Fruit Tablet, Chewable
FDA Label NDC 83455-127

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Extra Strength Antacid Tropical Fruit (NDC 83455-127). 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 750 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 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/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 2-4 tablets as symptoms occur, or as directed by a doctor.

Other Information

  • each tablet contains: elemental calcium 300 mg, magnesium 10mg
  • do not use if printed seal under cap is torn or missing. 
  • store below 30°C (86°F).

Inactive Ingredients

adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C yellow 10 lake, dextrose, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

Principal Display Panel

 

NDC 83455-127-22

 

*Compare to Tums® Extra Strength 750 active ingredient*


EQUALINE


extra strength

antacid tablets

Calcium Carbonate 750mg


relieves
heartburn and 
acid indigestion  

  

tropical fruit flavors

96 Chewable Tablets

  

127tf-96-eq.jpg (127tf 96 Eq)

127tf-96-eq.jpg (127tf 96 Eq)

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