Label: FERROUS SULFATE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 58607-113-10 - Packager: MARTIN EKWEALOR PHARMACEUTICALS, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated September 25, 2014
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children.
- Indications and Usage
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WARNINGS:
PRECAUTIONS:
WARNING: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a doctor. Occasional gastrointestinal discomfort like nausea may be minimized with meals. Iron-containing drugs may cause constipation or diarrhea.
PRECAUTIONS: Since oral iron products interfere with absorption of tetracycline antibiotics, these products should not be taken within two hours of each other. - DIRECTIONS:
- Other Ingredients:
- STORAGE:
- FERROUS SULFATE Product Label
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INGREDIENTS AND APPEARANCE
FERROUS SULFATE
ferrous sulfate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58607-113 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 CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM 20 mg Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) VANILLIN (UNII: CHI530446X) Product Characteristics Color red (RED) Score no score Shape ROUND (ROUND) Size 4mm Flavor Imprint Code NONE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58607-113-10 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/01/2014 Labeler - MARTIN EKWEALOR PHARMACEUTICALS, INC. (624528386) Registrant - MARTIN EKWEALOR PHARMACEUTICALS, INC (624528386) Establishment Name Address ID/FEI Business Operations MARTIN EKWEALOR PHARMACEUTICALS, INC 624528386 manufacture(58607-113)