FERROUS SULFATE- ferrous sulfate tablet, film coated
Sun Pharmaceutical Industries, Inc.

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 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57664-071
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	325 mg

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57664-071-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2014	12/31/2019
2	NDC:57664-071-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2014	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		07/01/2014	12/31/2019

FERROUS SULFATE
ferrous sulfate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57664-070
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	325 mg

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
CARNAUBA WAX (UNII: R12CBM0EIZ)
RIBOFLAVIN (UNII: TLM2976OFR)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	GREEN	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57664-070-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2014	12/31/2019
2	NDC:57664-070-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2014	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		07/01/2014	12/31/2019

Labeler - Sun Pharmaceutical Industries, Inc. (146974886)

Revised: 1/2020

Document Id: d017598d-6a28-4e31-a256-ed812769b194

Set id: bca6e06f-e9ea-4957-af87-453044fbf10b

Version: 2

Effective Time: 20200110

Sun Pharmaceutical Industries, Inc.