PNV-DHA Prenatal Vitamins
Generic Name: ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium and doconexent
Dosage Form: capsule, gelatin coated
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque and imprinted with “BP 321” on one side.
|Serving Size 1 Tablet|
|% DV||%DV for Pregnant
|Vitamin C||85 mg||142%||142%|
|Vitamin D3||200 IU||50%||50%|
|Vitamin E||10 IU||33%||33%|
|Vitamin D6||25 mg||1250%||1000%|
|(L-methylfolate calcium 676 mcg (as Xolafin-B™*)
molar equivalent to 600 mcg of Folic Acid)
|(folic acid, USP 400 mcg)|
|Vitamin B12||12 mcg||200%||150%|
|Iron (ferrous fumarate)||27 mg||150%||150%|
|Docosahexaenoic Acid (DHA)
(from omega-3 fatty acids)
OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3.
INDICATIONS: PNV-DHA is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING: 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 acquired predisposition to bleeding.
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.
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
HOW SUPPLIED: PNV-DHA is supplied in child-resistant bottles of 30 softgels (NDC# 42192-321-30).
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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.
MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
*Xolafin-B™ is a trademark of Acella Pharmaceuticals, LLC
PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets
Rx Prenatal Vitamin and DHA
Rx Only 30 Softgels
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent capsule, gelatin coated
|Labeler - Acella Pharmaceuticals, LLC (825380939)|