Vitamin Mineral Supplement
FDA Drug Information • Also known as: Concept Ob
- Brand Names
- Concept Ob
- Drug Class
- Vitamin C [EPC], Vitamin B12 [EPC], Nicotinic Acid [EPC]
- Route
- ORAL
- Dosage Form
- CAPSULE
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) .....................................130 mg (Equivalent to about 42.5 mg of Elemental Iron) PolysaccharideIronComplex .....................................92.4mg (Equivalent to about 42.5 mg of Elemental Iron) Vitamin C (from ProAscorb C‡)..................................... 210 mg Folic Acid ................................................................................... 1 mg Thiamine Mononitrate (B1)................................................. 5 mg Riboflavin (B2).......................................................................... 5 mg Niacin (B3)...............................................................................20 mg d-Calcium Pantothenate (B5)............................................. 7 mg Pyridoxine HCl (B6) ..............................................................25 mg Biotin (B7)........................................................................... 300 mcg Cyanocobalamin (B12) .....................................................10 mcg Copper (as Copper Sulfate)..........................................800 mcg Magnesium (as Magnesium Sulfate)............................6.9 mg Manganese (as Manganese Sulfate).............................1.3 mg Zinc (as Zinc Sulfate) ....................................................... 18.2 mg Inactive Ingredients: Hypromellose, Silicon Dioxide, Magnesium Stearate, Carmine, and Candurin Silver Fine. CLINICAL PHARMACOLOGY: Concept OBTM also supplies important prenatal vitamin minerals in a formulation that was especially designed to supplement the nutritional needs of pregnant women, before, during and after pregnancy. In Concept OBTM, patients receive the balanced support of 14 essential vitamins and minerals, including 1 mg of folic acid. The essential role of iron supplementation for pregnant women has long been recognized. Concept OBTM is unique in that it utilizes two (2) different forms of iron, i.e., Ferrous...
What Is Vitamin Mineral Supplement Used For?
INDICATIONS: Concept OBTM is a prenatal supplement designed to improve the nutritional status for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Concept OBTM may also be used to improve the nutritional status of women before conception.
Dosage and Administration
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. Do not administer to children under the age of 12.
Side Effects (Adverse Reactions)
Adverse Reactions: Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Concept OBTM after meals may control occasional G.I. disturbances. Concept OBTM is best absorbed when taken at bedtime.
Contraindications
CONTRAINDICATIONS: Concept OBTM is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
Overdosage
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. Concept OBTM should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of the reach of children. Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.
How Supplied
HOW SUPPLIED: Concept OB TM 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. Store at room temperature 15º to 30ºC (59º to 86ºF) and dry place. 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. Vcaps ® and the Vcaps ® Logo are trademarks used under license.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.