Label: FERROUS SULFATE tablet
- NHRIC Code(s): 54868-6324(NDC:0574-0608), 54868-6324-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0574-0608
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated November 5, 2012
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- Official Label (Printer Friendly)
- STATEMENT OF IDENTITY
- CONTAINS:
- DIRECTIONS FOR USE:
- WARNINGS
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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:
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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)
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PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
NDC 54868-6324-0
FERROUS SULFATE
ENTERIC-COATED TABLETS324 mg
Dietary
SupplementCONTAINS: 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
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INGREDIENTS AND APPEARANCE
FERROUS SULFATE
ferrous sulfate tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:54868-6324(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 SULFATE 324 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:54868-6324-0 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 12/19/2011 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 11 mm Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel