FERROUS SULFATE- ferrous sulfate, dried tablet, film coated 
SPIRIT PHARMACEUTICALS,LLC

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 USP 325 MG

Drug Facts

Active ingredients (in each Caplet)

Dried Ferrous Sulfate 325 mg

Purpose

Iron Supplement Therapy

Ferrous Sulphate is an iron supplement for iron deficiency and iron deficiency anemia when the need for such therapy has been determined by a physician.

Warnings

Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within tow hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing products may occasionally cause constipation or diarrhea.

If are pregnant or nursing a baby, seek the advise of a health professional before using this products.

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.

Direction

*
adults and children 12 years and over : take 1 tablet daily or as directed by a doctor
*
Children under 12 years : consult a physician..

Other information

*
Store at room temperature

Inactive ingredients

Starch USP, Calcium Carbonate USP, Guar Gum , Magnesium Stearate USP, Talc USP, Colloidal Silicon Dioxide USP, , Carnuba Wax

PRINCIPAL DISPLAY PANEL - 65 mg Tablet Carton

Ferrous
Sulfate

NDC # 68210-1520-0

Iron Supplement
Therapy

TAMPER EVIDENT –
SEE SIDE PANEL

100
TABLETS

PRINCIPAL DISPLAY PANEL - 65 mg Tablet Carton
FERROUS SULFATE 
ferrous sulfate, dried tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1520
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS SULFATE, DRIED (UNII: RIB00980VW) (IRON - UNII:E1UOL152H7) FERROUS SULFATE, DRIED 325 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
GUAR GUM (UNII: E89I1637KE)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
Color GREEN Score no score
Shape TRIANGLE Size 14mm
Flavor Imprint Code FS
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68210-1520-0 1 in 1 CARTON
1 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/15/2010
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

Revised: 12/2010
Document Id: 0fe4df43-f430-4cf1-9033-43387e7db002
Set id: 9fb466fe-9c2b-4014-9913-029348bda14c
Version: 1
Effective Time: 20101209
 
SPIRIT PHARMACEUTICALS,LLC