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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68210-1520
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE, DRIED (IRON) FERROUS SULFATE, DRIED325 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 
CALCIUM CARBONATE 
GUAR GUM 
MAGNESIUM STEARATE 
TALC 
SILICON DIOXIDE 
CARNAUBA WAX 
HYPROMELLOSES 
TITANIUM DIOXIDE 
FD&C YELLOW NO. 5 
FD&C BLUE NO. 2 
ALUMINUM OXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeTRIANGLESize14mm
FlavorImprint Code FS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-1520-01 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/15/2010
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