Concept-OB

Formulation re: Other

Prenatal Multivitamin & Mineral Supplement Capsules

Formula re: Type

Indications: Concept OB is a prenatal supplement designed to improve the nutritional status of women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Concept OB may also be used to improve the nutritional status of women before conception.

Precautions re: All Other

Contraindications: Concept OB is contraindicated in patients with a known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. It is also contraindicated in patients suffering from pernicious anemia as folic acid may obscure its signs and symptoms.

Formula re: Contains

Ferrous Fumarate and Polysaccharide Iron Complex (PIC): All concept products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending). "An increase in tolerability is observed with the formulation and is believed to occur as the result of distributing the total iron content in the composition among compounds that provide iron to the patient's blood stream via two different mechanisms. The ferrous salts are readily absorbed in the upper gut, by direct dissolution and absorption of the ferrous iron by the bloodstream. However, the iron available from PIC is absorbed in the lower gut, via an active protein transport mechanism.

Formula re: Contains

Folic Acid: Folic Acid is one of the important hematopoietic agents necessary for proper regeneration of the blood-forming elements and their function. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia.

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

PRECAUTIONS: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure the signs and symptoms of pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

Precautions re: All Other

OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted.

Suggested/Recommended/Usage/Directions

Dosage and Administration: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage.

Formulation re: Other

HOW SUPPLIED: Concept OB are pearl red-orange opaque Vcaps capsules printed in white with "Concept OB" on the cap and "US" Logo on the body. Packed in child-resistant cap and light resistant bottle of 30 capsules (52747-0620-30). The listed product number is not a National Drug Code. Instead, US Pharmaceutical Corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

Storage

Store at room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F) and dry place.

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

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

Vcaps and the Vcaps Logo are trademarks used under license.

General Statements: All Other Content

Consult package literature for full prescription information.

Formulation re: Other

Manufactured with Vcaps capsule shells. Manufactured in a FDA registered facility in the USA.

Precautions re: All Other

CAUTION: Rx only.

General Statements: All Other Content

Patent numbers: USA: 5,626,883; Mexico MX/a/2008/004461; Singapore: 200802623-9 and other countries.

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

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.

General Statements: All Other Content

Clinical Studies: Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias: PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No.3, pp. 213-220 (July-September 1982).

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

Ferrous Fumarate and Polysaccharide Iron Complex (PIC): All concept products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending).