FERROUS SULFATE by MARTIN EKWEALOR PHARMACEUTICALS, INC. / MARTIN EKWEALOR PHARMACEUTICALS, INC FERROUS SULFATE tablet

FERROUS SULFATE by

Drug Labeling and Warnings

FERROUS SULFATE by is a Otc medication manufactured, distributed, or labeled by MARTIN EKWEALOR PHARMACEUTICALS, INC., MARTIN EKWEALOR PHARMACEUTICALS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

FERROUS SULFATE 
ferrous sulfate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58607-113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	65 mg
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP)	CALCIUM	20 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (RED)	Score	no score
Shape	ROUND (ROUND)	Size	4mm
Flavor		Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58607-113-10	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2014

Labeler - MARTIN EKWEALOR PHARMACEUTICALS, INC. (624528386)

Registrant - MARTIN EKWEALOR PHARMACEUTICALS, INC (624528386)

Establishment
Name	Address	ID/FEI	Business Operations
MARTIN EKWEALOR PHARMACEUTICALS, INC		624528386	manufacture(58607-113)