Ferrous Sulfate by PD-Rx Pharmaceuticals, Inc. / Paddock Laboratories, LLC FERROUS SULFATE tablet

Ferrous Sulfate by

Drug Labeling and Warnings

Ferrous Sulfate by is a Other medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, Inc., Paddock Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Dietary Supplement

CONTAINS:

Each tablet contains 324 mg of ferrous sulfate, equivalent to 65 mg of elemental iron, providing 362% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

DIRECTIONS FOR USE:

Do not crush or chew tablets. Adult Serving Size: 1 tablet two to three times daily. Children: Consult a physician.

WARNINGS

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.

WARNINGS:

Do not take within 2 hours of taking oral tetracycline antibiotics, since oral iron products tend to interfere with absorption of tetracycline. May cause gastrointestinal discomfort, nausea, constipation or diarrhea. If you are pregnant or nursing a baby, seek advice of a health professional before using this product. U.S. Consumer Product Safety Commission requires that iron-containing medicines and vitamins with iron be packaged in child-resistant closures. Parents should always properly resecure safety closures.

STORAGE:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Supplement Facts

Serving Size 1 Tablet
Amount Per Tablet	% Daily Value
Iron (as ferrous sulfate)	65 mg	362%

Other ingredients: Corn Starch, Calcium Stearate, Powdered Cellulose, Lactose, Talc, Copovidone, Polyethylene Glycol, Maltodextrin, Sucrose, Povidone, Calcium Carbonate, Titanium Dioxide, Magnesium Stearate, Shellac, Cocoa Butter, FD&C Red No. 40 Aluminum Lake, Sodium Starch Glycolate A, Sodium Lauryl Sulfate, Colloidal Silicon Dioxide, Methacrylic Acid Copolymer Type C, Sodium Hydroxide, Simethicone Emulsion, Diethyl Phthalate, Hypromellose, Carnauba Wax, White Wax.

Packaged by: Paddock Laboratories, Inc.
Minneapolis, MN 55427

(01-08)

16 HOW SUPPLIED

Ferrous Sulfate Tablets are available as follows:

Each tablet contains 324mg of ferrous sulfate, equivalent to 65mg of elemental iron, providing 362% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

Available in bottles of 100 tablets (NDC: 72789-322-01)

PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label

NDC: 72789-322-01

Ferrous Sulfate
Enteric-Coated
Tablets

324 mg

Dietary
Supplement

Marketed and Packaged By:
PD-Rx Pharmaceuticals, Inc
Oklahoma City, OK 73127
1-405-942-3040 V.01.24.0

100 Tablets
TAMPER EVIDENT: DO NOT USE IF
SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

INGREDIENTS AND APPEARANCE

FERROUS SULFATE 
ferrous sulfate tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:72789-322(NDC:0574-0608)
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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CALCIUM STEARATE (UNII: 776XM7047L)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
TALC (UNII: 7SEV7J4R1U)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE (UNII: C151H8M554)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
CALCIUM CARBONATE (UNII: H0G9379FGK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SHELLAC (UNII: 46N107B71O)
COCOA BUTTER (UNII: 512OYT1CRR)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIETHYL PHTHALATE (UNII: UF064M00AF)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:72789-322-01	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		08/06/2012

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	11 mm

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Establishment
Name	Address	ID/FEI	Business Operations
PD-Rx Pharmaceuticals, Inc.		156893695	repack

Establishment
Name	Address	ID/FEI	Business Operations
Paddock Laboratories, LLC		967694121	LABEL, PACK