FERROUS SULFATE- iron supplement tablet 
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Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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FERROUS SULFATE TABLETS 325 mg (5 gr)

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.

FERROUS SULFATE (IRON SUPPLEMENT) TABLET

Label Image
FERROUS SULFATE 
iron supplement tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-5891(NDC:0603-0179)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 325 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color RED Score no score
Shape ROUND Size 8mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50436-5891-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/19/2001
Labeler - Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Business Operations
Unit Dose Services 831995316 REPACK(50436-5891) , RELABEL(50436-5891)

Revised: 7/2017
Document Id: 957f89f7-5aad-42ba-acf4-35e1359b6a5e
Set id: 91ff2cb4-1fb9-4125-9435-c9d008161203
Version: 4
Effective Time: 20170701
 
Unit Dose Services