Drug Facts
Composition & Profile
Identifiers & Packaging
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.]; PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets NDC 42192-321-30 PNV-DHA Rx Prenatal Vitamin and DHA Rx Only 30 Softgels Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - Film Coated Tablets
- 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.]
- PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets NDC 42192-321-30 PNV-DHA Rx Prenatal Vitamin and DHA Rx Only 30 Softgels Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - Film Coated Tablets
Overview
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. Supplement Facts Serving Size 1 Tablet Amount Per Serving % DV %DV for Pregnant or Lactating Women Vitamin C 85 mg 142% 142% Vitamin D 3 200 IU 50% 50% Vitamin E 10 IU 33% 33% Vitamin D 6 25 mg 1250% 1000% Folate 1 mg 250% 125% (L-methylfolate calcium 676 mcg (as Xolafin-B™ Percent Daily Values are based on a 2000 calorie diet ) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg) Vitamin B 12 12 mcg 200% 150% Calcium 140 mg 14% 11% Iron (ferrous fumarate) 27 mg 150% 150% Magnesium 45 mg 11% 10% Docosahexaenoic Acid (DHA) (from omega-3 fatty acids) 300 mg Daily Value (DV) not established 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.
Indications & Usage
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.
Dosage & Administration
: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
Warnings & Precautions
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.
Boxed 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.
Contraindications
: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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