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Ferrous Sulfate by Sun Pharmaceutical Industries, Inc.

Medically reviewed on December 11, 2017

Dosage form: tablet, film coated
Ingredients: FERROUS SULFATE 325mg
Labeler: Sun Pharmaceutical Industries, Inc.
NDC Code: 57664-071

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.

Ferrous Sulfate Film Coated Tablets

ACTIVE INGREDIENT(S)

EACH TABLET CONTAINS:



Dried Ferrous Sulfate, equivalent to 325 mg Ferrous Sulfate per tablet.
Amount per tablet  % Daily Value
 Iron 65 mg 361%

INACTIVE INGREDIENTS

Other ingredients for Red Tablets: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, sodium starch glycolate, hypromellose, stearic acid, polyethylene glycol (PEG) 400, FD&C red #40 aluminum lake, magnesium stearate, titanium dioxide, polyethylene glycol (PEG) 8000, carnauba wax

Other ingredients for Green Tablets: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, sodium starch glycolate, hypromellose, stearic acid, polyethylene glycol (PEG) 400, magnesium stearate, riboflavin, FD&C bule #1 aluminum lake, titanium dioxide, FD&C blue #2 aluminum lake, polyethylene glycol (PEG) 8000,  FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, carnauba wax

PURPOSE

Dietary Supplement

USE(S)

One tablet daily or as directed by a physician. For children under 12, consult a physician before using this product.

WARNINGS

Iron may interfere with absorpiton of certain antibiotics; these products should not be taken within two hours of each other.

Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking iron with meals. Iron-containing products may occassionally cause constipation or diarrhea. If pregnant or nursing consult a physicial before using this product.



DO NOT USE

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING

OTHER REQUIRED WARNINGS
 The information on this label has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, trea, cure or prevent any disease.


To report a serious adverse event or to obtain product information, contact 800-818-4555.



KEEP OUT OF REACH OF CHILDREN
 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.

DIRECTIONS

One tablet daily or as directed by a physician. For children under 12, consult a physical before using this product.

Do not exceed recommended dosage.

Do not use except under the advice and supervision of a physician.

STORAGE

Store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
FERROUS SULFATE 
ferrous sulfate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57664-071
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (FERROUS CATION) FERROUS CATION325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
CROSCARMELLOSE SODIUM 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSES 
STEARIC ACID 
POLYETHYLENE GLYCOL 400 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 8000 
CARNAUBA WAX 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:57664-071-101000 TABLET, FILM COATED in 1 BOTTLE
2NDC:57664-071-01100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/01/2014
FERROUS SULFATE 
ferrous sulfate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57664-070
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (FERROUS CATION) FERROUS CATION325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
CROSCARMELLOSE SODIUM 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSES 
STEARIC ACID 
POLYETHYLENE GLYCOL 400 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 8000 
CARNAUBA WAX 
RIBOFLAVIN 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
FD&C YELLOW NO. 6 
Product Characteristics
ColorGREENScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:57664-070-101000 TABLET, FILM COATED in 1 BOTTLE
2NDC:57664-070-01100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/01/2014
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Registrant - Sun Pharmaceutical Industries, Inc. (146974886)

 
Sun Pharmaceutical Industries, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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