Label: FERROUS SULFATE tablet
- NHRIC Code(s): 0574-0608-01, 0574-0608-11, 0574-0608-10
- Packager: Padagis US LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated October 30, 2024
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- 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.
Manufactured for Padagis®
Minneapolis, MN 55427
www.padagis.com02-23
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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
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INGREDIENTS AND APPEARANCE
FERROUS SULFATE
ferrous sulfate tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC: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:0574-0608-01 100 in 1 BOTTLE 2 NHRIC:0574-0608-11 10 in 1 CARTON 2 10 in 1 BLISTER PACK 3 NHRIC:0574-0608-10 1000 in 1 BOTTLE 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 size (solid drugs) 11 mm shape scoring 1 Labeler - Padagis US LLC (967694121)
