Label: HEMATRON-AF- ascorbic acid, dl-alpha tocopheryl acetate, l-5-methyltetrahydrofolate calcium, cyanocobalamin, biotin, carbonyl iron, cupric sulfate tablet
- NHRIC Code(s): 11026-2761-9
- Packager: Seyer Pharmatec, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated August 13, 2024
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STATEMENT OF IDENTITY
Supplement Facts Serving Size: 1 Tablet Amount % Daily Per Serving Value Vitamin C (as Ascorbic Acid) 500 mg 556% Vitamin E (as dl-Alpha Tocopheryl Acetate) 13.5 mg 90% Folate (as L-5-methyltetrahydrofolate Calcium) 1,020 mcg DFE 255% (600 mcg L-5-MTHF) Vitamin B12 (as Cyanocobalamin) 60 mcg 2,500% Biotin 150 mcg 500% Iron (as Carbonyl Iron) 150 mg 833% Copper (as Cupric Sulfate) 3 mg 333% *Daily Value not established. OTHER INGREDIENTS:
Microcrystalline Cellulose, Citric Acid, Stearic Acid, Dicalcium Phosphate, Croscarmellose Sodium, Polyvinylpyrrolidone, Hypromellose, Magnesium Stearate, Silicon Dioxide, Starch, Glucose, Calcium Carbonate, Crospovidone, Isomalt, Sodium Lauryl Sulfate, Maltodextrin, Triglycerides, Sucrose, Soy Polysaccharide, Glycerin, Mineral Oil, Polyethylene Glycol, Artificial French Vanilla Flavor, Annatto Extract (color), Propylene Glycol, Tricalcium Phosphate, Potassium Hydroxide, and Talc. Contains: SoyContains a bioengineered food ingredient.
HEMATRON AF is a multi-vitamin / multi-mineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency†
†This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. -
WARNINGS
WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately. DO NOT USE with individuals with a known hypersensitivity to any of the ingredients. Patients with hemochromatosis and hemosiderosis are contra-indications to iron therapy. This product is not for use in children under 12 years of age.
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CAUTION:
This product contains 1,020mcg DFE (600mcg L5-MTHF); the maximum safe Reference Daily Intake (RDI) amount for this nutrient is 1000mcg. Folic Acid in doses above 0.1 mg (1000mcg) daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive. There is a potential danger in administering folic acid to patients with undiagnosed anemia since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of Folic Acid.
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INGREDIENTS AND APPEARANCE
HEMATRON-AF
ascorbic acid, dl-alpha tocopheryl acetate, l-5-methyltetrahydrofolate calcium, cyanocobalamin, biotin, carbonyl iron, cupric sulfate tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:11026-2761 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 500 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 13.5 mg LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM 600 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 60 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 150 ug IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 150 mg CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 3 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) STEARIC ACID (UNII: 4ELV7Z65AP) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, RICE (UNII: 4DGK8B7I3S) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) CALCIUM CARBONATE (UNII: H0G9379FGK) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) ISOMALT (UNII: S870P55O2W) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MALTODEXTRIN (UNII: 7CVR7L4A2D) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SUCROSE (UNII: C151H8M554) SOYBEAN COTYLEDON CELL WALL POLYSACCHARIDES (UNII: 4UL6DF56YQ) GLYCERIN (UNII: PDC6A3C0OX) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) ANNATTO (UNII: 6PQP1V1B6O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:11026-2761-9 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 06/01/2024 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 21 mm scoring 3 imprint flavor Labeler - Seyer Pharmatec, Inc. (832947126)
