PNV-OB-DHA

Acella Pharmaceuticals, LLC

PNV - OB with DHA

FULL PRESCRIBING INFORMATION: CONTENTS*

• PRINCIPAL DISPLAY PANEL - 30 tablets

FULL PRESCRIBING INFORMATION

Rx Only

SUPPLEMENT FACTS
Each tablet contains:

OTHER INGREDIENTS (softgel): bovine gelatin, glycerin USP and water.

OTHER INGREDIENTS (tablet): dicalcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, stearic acid and silicon dioxide,

Uses

INDICATIONS: PNV - OB with 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, including individuals with known allergies to fish. PNV - OB with DHA does not contain fish, fish oils, fish proteins or fish byproducts.

CONTRAINDICATIONS: Folic acid (pteroylglutamic 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 (vitamin B₁₂).

WARNING: Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture of pernicious anemia, it does not ameliorate the attendant neurologic involvement. Resistance to treatment may be due to depressed hematopoiesis, alcoholism, the presence of anti-metabolic drugs and to deficiencies of vitamins. Prolonged use of iron salts may produce iron storage disease.

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or bleeding diathesis, individuals who have or suspected that they may have iron metabolism abnormalities should use caution in using supplemental iron. Iron supplementation in these individuals may lead to excess iron in the parenchyma of many organs. Iron storage and associated organ function tests may be indicated to ensure the delivery of needed iron to the neonate while ensuring the health of the mother.

PRECAUTIONS: Folic acid (pteroylglutamic acid) and Vitamin B12 microbiological blood assays are invalidated by the administration of most antibiotics, methotrexate and pyrimethamine. Folic acid (pteroylglutamic acid) is not effective reversing the toxic effects of methotrexate. Folinic acid (5-formyltetrahydrofolic acid) must be used in that situation. Black tarry stools may be due to either occult GI bleeding or iron therapy or both. Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses. In rare instances, allergic sensitization has been reported following both oral and parenteral administration of folic acid. Supplementation of the diet by milk or other dietary sources of Calcium may be advisable. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

ADVERSE REACTIONS: Allergic sensitivity reactions and gastrointestional disturbances may occur.

DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, one tablet and one softgel daily,or as directed by a physician.

HOW SUPPLIED: 42192-352-60. PNV - OB with DHA is supplied in child-resistant blister cards containing 30 doses per carton (1 tablet and 1 golden - colored DHA softgel capsule equals 1 daily dose). Each unit-of-use dispensing carton contains 5 cards with 6 unit-doses per card which is a 30-day supply. The brown tablet is imprinted with “352” on one side and is blank on the other. The golden - colored DHA softgel capsule is not imprinted. The listed product number is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein. 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.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC • Alpharetta, GA 30022 • 1-800-541-4802

Rev 0313

PRINCIPAL DISPLAY PANEL - 30 tablets

42192-352-60

PNV - OB with DHA

Prenatal Nutritional Supplement

Rx Only

With Omega-3 (DHA) and 15 important
vitamins and minerals

30 day supply - 30 tablets and 30 softgel capsules

Acella
PHARMACEUTICALS, LLC