FERROUS SULFATE- iron supplement tablet 
Qualitest Pharmaceuticals

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.

Package Label

bc435fed-figure-01
bc435fed-figure-02

FERROUS SULFATE TABLETS 325 mg (5 gr)

Iron Supplement

NDC: 0603-0179-29 – (100 Tablets (4 x 25) Unit Dose

NDC: 0603-0179-32 – 1000 TABLETS

FERROUS SULFATE 
iron supplement tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0179
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0179-29100 in 1 BLISTER PACK; Type 0: Not a Combination Product02/19/200103/31/2018
2NDC:0603-0179-321000 in 1 BOTTLE; Type 0: Not a Combination Product02/19/200103/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/200103/30/2020
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical, Inc.078301063MANUFACTURE(0603-0179)

Revised: 4/2013
 
Qualitest Pharmaceuticals