Prescribing Information | PNV OB DHA

PharmaPure Rx PNV OB + DHA is a prescription prenatal/postnatal multivitamin/mineral caplet and a softgel of an essential fatty acid. The prenatal vitamin is a light purple, capsule-shaped multivitamin/mineral caplet. The caplet is imprinted with the code "P-116" on one side and is blank on the other side. The essential fatty acid DHA softgel is clear and contains a pale yellow semi-solid mixture.

Other ingredients in DHA caplet: Croscarmellose Sodium, Crospovidone, FD and C Blue #2 Aluminum Lake, Gelatin, Hydrogenated Soybean Oil, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Polysorbate 80, Povidone, Red Iron Oxide, Silicon Dioxide, Starch, Stearic Acid, Sucrose, Titanium Dioxide, Triacetin.

PNV OB+DHA is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Before, during and after pregnancy, one caplet and one softgel taken by mouth daily, or as prescribed by a physician. The caplet and softgel may be taken together or at different times of the day.

PNV OB+DHA is contraindicated in patients with a known hypersensitivity  to any of the ingredients.

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.

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and reduced clotting ratio (INR). Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient.

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Exercise caution to ensure that the prescribed dosage of DHA doses not exceed 1 gram (1,000 mg) per day.

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Caution should be exercised with patients with known allergies to fish or fish by-products. Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

PNV OB+DHA is not indicated for pediatric or geriatric use.

PNV OB+DH A (NDC 59088-115-60) is a 30-day regimen supplied as six child-resistant blister cards each containing 5 light purple PNV OB+DHA prenatal capsule-shaped caplets NDC:59088-116-54 imprinted "P-116" and 5 pale yellow DHA softgels NDC: 59088-117-54 each.

Store at temperature 20°-25°C (68°-77°F).[See USP Controlled Room Temperature]. Keep in a cool, dry place.

Manufacturer

PureTek Corporation

Active Ingredients

Source

• U.S. National Library of Medicine
• DailyMed
• Last Updated: 4 May 2013