Label: FERROUS SULFATE- ferrous sulfate 325 mg green tablet, film coated
- NHRIC Code(s): 16103-382-08, 16103-382-11
- Packager: Pharbest Pharmaceuticals, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated July 23, 2019
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Supplement Facts
Serving Size 1 Tablet
Servings Per Container 1000
Amount Per Serving % Daily Value Iron (as ferrous sulfate) 65 mg 361% Other ingredients: croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin
Formula: Each tablet contains 202 mg of dried ferrous sulfate USP (65 mg of elemental iron), equivalent to 325 mg of ferrous sulfate USP.
- Directions:
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Caution:
Since oral iron products interfere with absorption of certain antibiotics; these products should not be taken within two hours of each other. if you are pregnant, nursing or taking any medications, consult your doctior befoe use. Discontinue use and consult your doctor if any adverse reactions occur.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately. - SAFE HANDLING WARNING
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INGREDIENTS AND APPEARANCE
FERROUS SULFATE
ferrous sulfate 325 mg green tablet, film coatedProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:16103-382 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:16103-382-08 100 in 1 BOTTLE, PLASTIC 2 NHRIC:16103-382-11 1000 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 07/22/2019 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 10 mm Labeler - Pharbest Pharmaceuticals, Inc. (557054835) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 manufacture, analysis, pack, label