FERROUS SULFATE- ferrous sulfate tablet 
Paddock Laboratories, LLC

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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)

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

Perrigo®

NDC 0574-0608-01

Ferrous Sulfate
Enteric-Coated Tablets

324 mg

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.

Net Contents 100 Tablets

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
FERROUS SULFATE 
ferrous sulfate tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC: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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (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:0574-0608-01100 in 1 BOTTLE
2NHRIC:0574-0608-1110 in 1 CARTON
210 in 1 BLISTER PACK
3NHRIC:0574-0608-101000 in 1 BOTTLE
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 - Paddock Laboratories, LLC (967694121)
Establishment
NameAddressID/FEIBusiness Operations
Paddock Laboratories, LLC967694121LABEL, PACK
Establishment
NameAddressID/FEIBusiness Operations
Quality By Design Packaging, Inc.830254210PACK
Establishment
NameAddressID/FEIBusiness Operations
Lomapharm Rudolf Lohmann GmbH KG315866525MANUFACTURE

Revised: 8/2017
Document Id: fc183b72-f39c-4ed1-b64f-d2ecf9b2807c
Set id: 662cc31c-e977-4f7b-b9e4-3d932982103c
Version: 5
Effective Time: 20170823
 
Paddock Laboratories, LLC