Extra Strength Antacid Smooth Dissolve Assorted Fruit Tablet, Chewable
FDA Label NDC 83455-173

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 Smooth Dissolve Assorted Fruit (NDC 83455-173). 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)

→ 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

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

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 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.

Other Information

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

Inactive Ingredients

adipic acid, corn starch, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C red 40 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose, talc.