Hemocyte Plus Capsules

General Statements: All Other Content

NDC 52747-0800-30 30 capsules Rx only

Formula re: Contains

Iron/Folic Acid/Vitamin Supplement Capsules

Precautions re: Children

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.

Precautions re: All Other

Warning: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

Precautions re: All Other

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.

Formula re: Type

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.

Precautions re: All Other

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.

Precautions re: Children

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.

Precautions re: All Other

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.

Precautions re: Children

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Precautions re: Allergies

Adverse reaction: Allergic reactions have been reported following both oral and parenteral administration of folic acid.

Suggested/Recommended/Usage/Directions

Dosage and administration: Adults only: 1 capsule daily, between meals, orally. Do not exceed recommended dosage. Do not administer to children.

General Statements: All Other Content

How supplied: Maroon cap and body printed "US" logo in black. Child resistant blister packs in containers of 100 capsules (NDC 52747-800-60) and containers of 30 capsules (NDC 52747-800-30).

Storage

Store at room temperature between 15(0)-30(0)C (59(0)-86(0)F). Keep in Cool Dry Place.

Precautions re: All Other

Caution: Rx only.

Brand IP Statement(s) re: (c), (TM), (SM)

Copyright 2001 - 2018 US Pharmaceutical Corporation. All rights reserved.

FDA Statement of Identity

Iron/Folic Acid/Vitamin Supplement Capsules

Precautions re: All Other

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.l. disturbances may be controlled by giving Hemocyte Plus Capsules shortly after meals.