Pnv-dha

Pnv-dha
SPL v3
SPL
SPL Set ID 038fe2e7-dc16-485c-b5fb-746db7231347
Route
ORAL
Published
Effective Date 2013-04-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ascorbic Acid (85 [iU]) Cholecalciferol (200 [iU]) .alpha.-tocopherol, Dl- (10 [iU]) Pyridoxine (25 [iU]) Folic Acid (1 mg) Cyanocobalamin (12 ug) Calcium (140 mg) Ferrous Cation (27 mg) Magnesium (45 mg) Doconexent (300 mg)
Inactive Ingredients
Carnauba Wax Corn Oil Lecithin, Soybean Gelatin Glycerin Water Titanium Dioxide Fd&c Blue No. 1 Fd&c Red No. 3

Identifiers & Packaging

Pill Appearance
Imprint: BP;321 Shape: capsule Color: blue Size: 25 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2009-11-02

Description

Rx Only


Medication Information

Recent Major Changes

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.

Warnings and 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.

Indications and 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 and Administration

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

Dosage Forms and Strengths

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.]

Contraindications

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Description

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.

Section 34084-4

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Section 42229-5

Rx Only

Section 42232-9

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.

Section 51727-6

OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3.

Principal Display Panel 30 Softgel Tablets

NDC 42192-321-30

PNV-DHA

Rx Prenatal Vitamin and DHA

Rx Only           30 Softgels

Acella

PHARMACEUTICALS, LLC


Structured Label Content

Recent Major Changes (34066-1)

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.

Indications and Usage (34067-9)

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 and Administration (34068-7)

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

Dosage Forms and Strengths (34069-5)

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.]

Contraindications (34070-3)

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings and Precautions (34071-1)

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.

Section 34084-4 (34084-4)

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Description (34089-3)

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.

Section 42229-5 (42229-5)

Rx Only

Section 42232-9 (42232-9)

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.

Section 51727-6 (51727-6)

OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3.

Principal Display Panel 30 Softgel Tablets (PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets)

NDC 42192-321-30

PNV-DHA

Rx Prenatal Vitamin and DHA

Rx Only           30 Softgels

Acella

PHARMACEUTICALS, LLC


Advanced Ingredient Data


Raw Label Data

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