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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

Ferrous Sulfate Product Label

The following document was submitted to the FDA by the labeler of this product Unit Dose Services. 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 mg360 %

Suggested Use



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


Active Ingredient



U.S. RDA* EACH TABLET CONTAINS:                  %

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. . In case of accidental overdose, call a doctor or Poison Control Center immediately. Keep this product out of reach of children

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. WARNINGS: Do not exceed recommended dosage.

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



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. Each tablet contains:


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.


* Please review the disclaimer below.