Label: FERROUS SULFATE tablet
- NHRIC Code(s): 72789-322(NDC:0574-0608), 72789-322-01
- Packager: PD-Rx Pharmaceuticals, 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 January 12, 2024
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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)
- 16 HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label
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INGREDIENTS AND APPEARANCE
FERROUS SULFATE
ferrous sulfate tabletProduct 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