FERROUS SULFATE - ferrous sulfate tablet 
Physicians Total Care, 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)

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 54868-6324-0

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

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


FERROUS SULFATE 
ferrous sulfate tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:54868-6324(NDC:0574-0608)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS SULFATE324 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CALCIUM STEARATE (UNII: 776XM7047L)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
LACTOSE (UNII: J2B2A4N98G)  
TALC (UNII: 7SEV7J4R1U)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE (UNII: C151H8M554)  
POVIDONE (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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:54868-6324-0100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT12/19/2011
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)11 mm
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 11/2012
Document Id: 0a7e7223-6110-4f2f-9240-4fe8af7ac4c9
Set id: fa8c6222-9641-429c-a4e2-9d2743bfdb61
Version: 2
Effective Time: 20121105
 
Physicians Total Care, Inc.