Legend Premium Heartburn Chewable Relief
FDA Label NDC 13411-845

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 Relief (NDC 13411-845). 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, 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 Ingredient

Calcium carbonate 500 mg.

Purpose

  • Antacid

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.

Uses For The Relief Of


● acid indigestion

● heartburn

● sour stomach

● upset stomach associated with these symptoms

Directions

● adults and children 12 years and over: fully chew then swallow 2 to 3 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 200 mg
● store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive Ingredients

Dextrose monohydrate, Saccharin sodium, Sucrose, Dokudami extract, FD&C Blue No. 1, FD&C yellow No. 5, Povidone K30, Water, Xylitol, Sorbitol, Magnesium Stearate, Peppermint, Silicon Dioxide

* Please review the disclaimer below.