Label: HEMOCYTE PLUS- iron-vitamin-mineral complex supplement capsule
- NHRIC Code(s): 52747-800-30
- Packager: U.S. Pharmaceutical Corporation
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated June 14, 2023
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STATEMENT OF IDENTITY
Supplement Facts
Serving Size: 1 Capsule
Amount Per Serving %DV* %DVPLW** Vitamin C (as Sodium Ascorbate) 187 mg 208% 156% Vitamin B1 (as Thiamine Hydrochloride) 10 mg 833% 714% Vitamin B2 (Riboflavin) 6 mg 462% 375% Vitamin B3 (as Niacinamide) 30 mg 188% 167% Vitamin B6 (Pyridoxine HCl) 5 mg 294% 250% Folic Acid 1 mg 250% 167% Vitamin B12 (Cyanocobalamin) 15 mcg 625% 536% Pantothenic Acid
(as D-Calcium Pantothenate)10 mg 200% 143% Iron (from Ferrous Fumarate) 106 mg 589% 393% Magnesium (as Magnesium Sulfate) 6.9 mg 2% 2% Zinc (as Zinc Sulfate) 18 mg 164% 138% Copper (as Copper Sulfate) 0.8 mg 89% 62% Manganese (as Manganese Sulfate) 1.3 mg 57% 50% *% Daily Values are based on a 2,000 calorie intake of adults and children 12 years and older. **% Daily Value for Pregnant or Lactating Women Other Ingredients: Dibasic Calcium Phosphate, Gelatin, Magnesium Stearate, Silicon Dioxide, Titanium Dioxide, FD&C RED #40 and FD&C Blue #2
INDICATIONS: For the treatment of iron deficiency anemia and folate deficiency as normally found in chronic extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for correction of conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.
CONTRAINDICATIONS: HEMOCYTE PLUS® CAPSULES are contraindicated in patients with a known hypersensitivity to any of its ingredients. Also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, and hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
In case of accidental overdose call a doctor or poison control center immediately. Iron is toxic. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. HEMOCYTE PLUS® CAPSULES should be stored beyond the reach of children to protect against accidental iron poisoning. Keep this and all drugs out of the reach of children.
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WARNINGS
WARNING: 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. WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036.
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PRECAUTIONS
PRECAUTIONS: General: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
PEDIATRIC USE: Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTION:
Allergic reactions have been reported following both oral and parenteral administration of folic acid. Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy and physician encouragement. Although the absorption of iron is best when taken between meals, occasional G.I. disturbances may be controlled by giving HEMOCYTE PLUS® CAPSULES shortly after meals. -
DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION: Adults only: 1 capsule daily, between meals, orally. Do not exceed recommended dosage. Do not administer to children.
HOW SUPPLIED: HEMOCYTE PLUS® CAPSULES are maroon capsules printed in black with "US" logo on both cap and body. Available in boxes of 30 blisterpacked capsules (52747-0800-30) and 100 blisterpacked capsules (52747-0800-60). The listed product numbers are not National Drug Codes. Instead, US Pharmaceutical Corporation has assigned these product codes formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.
- SAFE HANDLING WARNING
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HEALTH CLAIM
Iron-Vitamin-Mineral Complex Supplement
RESERVED FOR PROFESSIONAL RECOMMENDATION. Made in the USA exclusively for US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036. All rights reserved. The appearance and the name of Hemocyte Plus® CAPS or Hemocyte Plus® CAPSULES are trademarks of US Pharmaceutical Corporation. The appearance of the Iron / Vitamin / Mineral combination is a trademark of US Pharmaceutical Corporation. The use of the product information pamphlet is expressly prohibited without prior written consent.
- Packaging
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INGREDIENTS AND APPEARANCE
HEMOCYTE PLUS
iron-vitamin-mineral complex supplement capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:52747-800 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 187 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE MONONITRATE 10 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 6 mg NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 30 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 5 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 0.015 mg PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 10 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 106 mg MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM 6.9 mg ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 18 mg CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 0.8 mg MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANOUS CATION - UNII:H6EP7W5457) MANGANOUS CATION 1.3 mg Inactive Ingredients Ingredient Name Strength GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:52747-800-30 3 in 1 BOX 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 02/01/2004 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 22 mm scoring 1 imprint Labeler - U.S. Pharmaceutical Corporation (079467662)