Label: FERROUS SULFATE- ferrous sulfate, dried tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 68210-1520-0 - Packager: SPIRIT PHARMACEUTICALS,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 9, 2010
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- SPL UNCLASSIFIED SECTION
- Active ingredients (in each Caplet)
- Purpose
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Warnings
Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within tow hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing products may occasionally cause constipation or diarrhea.
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- PRINCIPAL DISPLAY PANEL - 65 mg Tablet Carton
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INGREDIENTS AND APPEARANCE
FERROUS SULFATE
ferrous sulfate, dried tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1520 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS SULFATE, DRIED (UNII: RIB00980VW) (IRON - UNII:E1UOL152H7) FERROUS SULFATE, DRIED 325 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) CALCIUM CARBONATE (UNII: H0G9379FGK) GUAR GUM (UNII: E89I1637KE) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSES (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color GREEN Score no score Shape TRIANGLE Size 14mm Flavor Imprint Code FS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-1520-0 1 in 1 CARTON 1 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 12/15/2010 Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)