Legend Premium Heartburn Chewable
FDA Label NDC 13411-844

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals for the product Legend Premium Heartburn Chewable (NDC 13411-844). 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 ingredients, purpose, warnings, uses for the relief of, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Calcium carbonate 750 mg.

Simethicone 80 mg.

Purpose

  • Antacid
  • Antigas

Warnings


Do not use if you have ever had an allergic reaction to this product or any of its ingredients

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 5 chewable tablets in a 24-hour period
● Do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
● Constipation may occur

If pregnant or breast-feeding, ask a health professional before use.
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Uses For The Relief Of


● acid indigestion
● heartburn
● sour stomach
● upset stomach associated with these symptoms
● bloating, pressure, or stuffed feeling commonly referred to as gas

Directions

● adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.
● children under 12 years: consult a doctor
● do not take more than 5 chewable tablets in a 24-hour period.

Other Information

● each chewable tablet contains: calcium 300 mg
● store at room temperature. Avoid excessive heat above 40oC (104 F).

Inactive Ingredients

Dextrose monohydrate, Saccharin sodium, Sucrose, Dokudami extract, FD&C Red No. 3, Povidone K30, Water, Xylitol, Sorbitol, Magnesium Stearate, Peppermint, Silicon Dioxide

* Please review the disclaimer below.