Ferrous Sulfate Tablet
FDA Label NDC 54738-963

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Richmond Pharmaceuticals, Inc. for the product Ferrous Sulfate (NDC 54738-963). 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 inactive ingredients:, warnings:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Inactive Ingredients:

croscarmellose sodium, dicalcium phosphate, FD&C red #40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide

Warnings:

Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

* Please review the disclaimer below.