FERROUS SULFATE tablet, film coated

Ferrous Sulfate by

Drug Labeling and Warnings

Ferrous Sulfate by is a Otc medication manufactured, distributed, or labeled by Central Texas Community Health Centers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

HOW SUPPLIED

Product: 76413-356

NDC: 76413-356-01 100 TABLET, FILM COATED in a BOTTLE

FERROUS SULFATE TABLET, FILM COATED

INGREDIENTS AND APPEARANCE

FERROUS SULFATE 
ferrous sulfate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76413-356(NDC: 57664-070)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76413-356-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		07/01/2014

Labeler - Central Texas Community Health Centers (079674019)

Establishment
Name	Address	ID/FEI	Business Operations
Central Texas Community Health Centers		079674019	RELABEL(76413-356) , REPACK(76413-356)