FERROUS SULFATE- ferrous sulfate tablet 
PD-Rx Pharmaceuticals, Inc.

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FERROUS SULFATE
ENTERIC-COATED TABLETS

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.

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 mg362%

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.

PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label
FERROUS SULFATE 
ferrous sulfate tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:72789-322(NDC:0574-0608)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:72789-322-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT08/06/2012
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)11 mm
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack
Establishment
NameAddressID/FEIBusiness Operations
Paddock Laboratories, LLC967694121LABEL, PACK

Revised: 1/2024
Document Id: 117062b5-dbc6-47b1-8ef4-545d64fb389e
Set id: 0f4fe0f3-3472-4da6-83a0-ff20a0e23c83
Version: 7
Effective Time: 20240112
 
PD-Rx Pharmaceuticals, Inc.