Label: FERROUS SULFATE- iron supplement tablet
- NDC Code(s): 50436-5891-1
- Packager: Unit Dose Services
- This is a repackaged label.
- Source NDC Code(s): 0603-0179
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated July 1, 2017
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- Supplement Facts[/S]
Serving Size: 1 Tablet
Amount per Tablet
% Daily Value Iron (as ferrous sulfate) 65 mg 360 %
- SUGGESTED USE
Adults: One (1) tablet daily, preferably after meals or as directed by the doctor. Children: As directed by the doctor.Close
- Active Ingredient
EACH TABLET CONTAINS: % U.S. RDA*
Elemental Iron 65 mg 360
(Equivalent to 325 mg of Ferrous Sulfate)
* U.S. Recommended Daily AllowanceClose
- Inactive Ingredients
Croscarmellose sodium, dicalcium phosphate, FD&C RED#40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxideClose
Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.
WARNINGS: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea.
As with any drug, if you are pregnant or nursing baby, seek the advice of a health professional before using this product.Close
- DRUG INTERACTION PRECAUTION
Since oral iron products interfere with absorption of oral tetracycline antibiotics , these products should not be taken within two hours of each other.Close
- DOSAGE AND ADMINISTRATION
Each tablet contains: Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture.Close
- Questions or Comments
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS BROKEN OR DAMAGED
Distributed by: Qualitest Pharmaceuticals, Inc.Close
- FERROUS SULFATE (IRON SUPPLEMENT) TABLET
- INGREDIENTS AND APPEARANCE
iron supplement tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-5891(NDC:0603-0179) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 325 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50436-5891-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/2001 Labeler - Unit Dose Services (831995316) Establishment Name Address ID/FEI Business Operations Unit Dose Services 831995316 REPACK(50436-5891) , RELABEL(50436-5891)