Fw Extra Strength Af Smooth Antacid Tablet, Chewable
FDA Label NDC 55319-925

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services, Inc. for the product Fw Extra Strength Af Smooth Antacid (NDC 55319-925). 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

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, magnesium 10mg
  • 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.

Principal Display Panel

FAMILY WellnessTM

COMPARE TO THE ACTIVE INGREDIENT IN TUMS® SMOOTHIESTM E-X*


EXTRA STRENGTH
ANTACID TABLETS

SMOOTH DISSOLVE
Calcium Carbonate 750 mg

ASSORTED FRUIT FLAVORS

NDC 55319-925-23
60 CHEWABLE TABLETS


173af-fw-label (173af Fw Label)

173af-fw-label (173af Fw Label)



173af-fw (173af Fw)

173af-fw (173af Fw)

* Please review the disclaimer below.