Ferrous Sulfate
FDA Label NDC 53808-0918

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by State Of Florida Doh Central Pharmacy for the product Ferrous Sulfate (NDC 53808-0918). 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 supplement facts[/s], suggested use, active ingredient, inactive ingredients, purpose, warning:, drug interaction precaution, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Supplement Facts[/S]

Serving Size: 1 Tablet
Amount per Tablet		% Daily Value
Iron (as ferrous sulfate)  65 mg 360 %

Suggested Use

Adults: One (1) tablet daily, preferably after meals or as directed by the doctor. Children: As directed by the doctor.

Active Ingredient

EACH TABLET CONTAINS:                  % U.S. RDA*

Elemental Iron 65 mg     360

(Equivalent to 325 mg of Ferrous Sulfate)

* U.S. Recommended Daily Allowance 

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

Purpose

Iron Supplement

Warning:

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

WARNINGS: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of 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 baby, seek the advice of a health professional before using this product.   

Drug Interaction Precaution

Since oral iron products interfere with absorption of oral tetracycline antibiotics , these products should not be taken within two hours of each other.

Dosage And Administration

Each tablet contains: Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture.

Questions Or Comments

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS BROKEN OR DAMAGED

Distributed by: Qualitest Pharmaceuticals, Inc.

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

Package Label

Label Image for 53808-0918
325mg

* Please review the disclaimer below.