FERROUS SULFATE- ferrous sulfate tablet, film coated 
Central Texas Community Health Centers

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 - 325 MG Tablet Bottle Label

CommUnityCare Federally Qualified Health Centers

FERROUS
SULFATE
325MG #
100

Date:

Name:
Dr.

TAKE 1 TABLET 1 TO 3 TIMES PER DAY WITH FOOD, AS
DIRECTED.

123456

1/1/01

FERROUS SULF 325MG TABS# 100 NDC 76413-308-01

Batch: 123456
Lot: 123456
Exp: 1/1/01
SUN PHARMA

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 325 MG Tablet Bottle Label
FERROUS SULFATE 
ferrous sulfate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-308(NDC:57664-071)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSES (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
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76413-308-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/01/2014
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIBusiness Operations
Central Texas Community Health Centers079674019REPACK(76413-308) , RELABEL(76413-308)

Revised: 3/2016
Document Id: 909b743b-50a1-4bb6-afbf-87a8b12157d1
Set id: c57a8573-d5ae-48b2-afb7-bbec2f63afff
Version: 1
Effective Time: 20160322
 
Central Texas Community Health Centers