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Concept OB

RxNorm 1314666· VITAMIN MINERAL SUPPLEMENT· ORAL

Vitamin C [EPC], Vitamin B12 [EPC], Nicotinic Acid [EPC] · U.S. Pharmaceutical Corporation

Indications and usage

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.

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 for pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. PRECAUTIONS: General: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

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.

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • atrial septal defect2
  • foetal exposure during pregnancy2
  • maternal exposure during pregnancy2
  • neonatal respiratory distress syndrome2
  • pre-eclampsia2
  • abdominal pain lower1
  • abnormal behaviour1
  • affect lability1
  • alopecia1
  • anger1
  • anxiety1
  • arrhythmia1
  • autism spectrum disorder1
  • caesarean section1
  • chest discomfort1
  • chordee1

Adverse reactions (label)

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.

KR · 한국Products in Korea (2376)

View more: Full FDA label on DailyMed →Label effective 20221108