FERROUS SULFATE - ferrous sulfate tablet 
MARTIN EKWEALOR PHARMACEUTICALS, 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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Active Ingredients

Supplemental Facts

Serving Size 1 Tablet              Servings per Container 100

Amount Per Tablet                   % Daily Value

Iron (as Ferrous Sulfate)           65 mg      361%

Calcium                                  20 mg         2%

Purpose

NATURAL IRON SUPPLEMENT

Keep out of reach of children.

WARNING: Accidental overdose of iron-containing  products is a leading cause of poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Indications and Usage

NATURAL IRON SUPPLEMENT. The treatment of any anemic condition should be under the advise and supervision of a doctor.

WARNINGS: PRECAUTIONS:

WARNING: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a doctor. Occasional gastrointestinal discomfort like nausea may be minimized with meals. Iron-containing drugs may cause constipation or diarrhea.


PRECAUTIONS: Since oral iron products interfere with absorption of tetracycline antibiotics, these products should not be taken within two hours of each other.

DIRECTIONS:

Adults only. One tablet daily, preferably with a meal or as directed by a physician.

Other Ingredients:

Dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, FD and C red #40 (AL Lake), FD and C blue #2/Indigo Carmine (Al Lake), macrogol, PEG 400, silicon dioxide, titanium dioxide, talc, vanillin.

STORAGE:

Store between 15° - 30° C (59° -86° F)

FERROUS SULFATE Product Label

58607-113-10

NATURAL IRON SUPPLEMENT

FERROUS SULFATE
5 gr (325 mg)

100 Tablets

MADE WITH PRIDE IN THE U.S.A.

M.E. Pharmaceuticals, Inc.
Richmond, IN 47374

Lot No:
Exp Date:

MEPharm FerrousSulfate Label

FERROUS SULFATE 
ferrous sulfate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58607-113
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM20 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
VANILLIN (UNII: CHI530446X)  
Product Characteristics
Colorred (RED) Scoreno score
ShapeROUND (ROUND) Size4mm
FlavorImprint Code NONE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58607-113-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2014
Labeler - MARTIN EKWEALOR PHARMACEUTICALS, INC. (624528386)
Registrant - MARTIN EKWEALOR PHARMACEUTICALS, INC (624528386)
Establishment
NameAddressID/FEIBusiness Operations
MARTIN EKWEALOR PHARMACEUTICALS, INC624528386manufacture(58607-113)

Revised: 9/2014
Document Id: 07283557-cfb0-4689-8e9e-a0dd5c061fda
Set id: b4189b86-b109-4828-9bcb-38e9dbc248db
Version: 1
Effective Time: 20140925
 
MARTIN EKWEALOR PHARMACEUTICALS, INC.