Select-OB Plus DHA Prenatal Supplement Plus DHA

Select-OB Plus DHA Prenatal Supplement Plus DHA is an FDA-registered drug product whose active ingredient is .BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, COBALAMIN, IRON, MAGNESIUM OXIDE, ZINC OXIDE, AND DOCONEXANT. It is labelled by Exeltis USA, Inc. and marketed as a human prescription drug product. Identifiers on file: NDC 0642-0075, label effective 20230724. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing .BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, COBALAMIN, IRON, MAGNESIUM OXIDE, ZINC OXIDE, AND DOCONEXANT are most often described in connection with: select-ob dha, indicated provide, vitamin mineral, omega- fatty, acid supplementation, prior conception, throughout pregnancy, postnatal period. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Select-OB+DHA ® is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.* Select-OB+DHA ® does not contain fish, fish oils, fish proteins or fish byproducts.

DOSAGE AND ADMINISTRATION Before, during and after pregnancy, chew or swallow one blue Select OB ® caplet and swallow one DHA softgel capsule daily, or as directed by a physician.

CONTRAINDICATIONS Select-OB+DHA ® is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitaminB12).

WARNINGS/PRECAUTIONS Select-OB+DHA ® should be used with caution in patients with known sensitivity or allergy to soy. Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased rick of heart disease can occur. Prolonged use of iron slats may produce iron storage disease. Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended. Avoid overdosage. Keep out of the reach of children. Drug Interactions High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions. Information for Patients Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding. Pediatric Use Not for pediatric use.

ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Select-OB+DHA ® .

What is Select-OB Plus DHA Prenatal Supplement Plus DHA used for?
INDICATIONS AND USAGE Select-OB+DHA ® is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.* Select-OB+DHA ® does not contain fish, fish oils, fish proteins or fish byproducts.

Who makes Select-OB Plus DHA Prenatal Supplement Plus DHA?
Exeltis USA, Inc. is the labeler of record for Select-OB Plus DHA Prenatal Supplement Plus DHA.

Is Select-OB Plus DHA Prenatal Supplement Plus DHA prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Select-OB Plus DHA Prenatal Supplement Plus DHA been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.