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  5. Label Information: Ferrous Sulfate

FDA Label for Ferrous Sulfate

View Indications, Usage & Precautions

Table of Contents

    1. SUPPLEMENT FACTS[/S]
    2. SUGGESTED USE
    3. ACTIVE INGREDIENT
    4. INACTIVE INGREDIENTS
    5. PURPOSE
    6. WARNING:
    7. DRUG INTERACTION PRECAUTION
    8. DOSAGE AND ADMINISTRATION
    9. QUESTIONS OR COMMENTS
    10. PACKAGE LABEL

Ferrous Sulfate Product Label

The following document was submitted to the FDA by the labeler of this product State Of Florida Doh Central Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.