Pnv-select

Pnv-select
SPL v3
SPL
SPL Set ID 9f4ce551-7a80-4ddb-a014-95c44b54a420
Route
ORAL
Published
Effective Date 2012-08-31
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Vitamin A (2500 [iU]) Ascorbic Acid (80 mg) Cholecalciferol (400 [iU]) .alpha.-tocopherol, Dl- (10 [iU]) Riboflavin (3 mg) Niacinamide (3.4 mg) Pyridoxine (20 mg) Folic Acid (1 mg) Cyanocobalamin (12 ug) Biotin (300 ug) Pantothenic Acid (6 mg) Calcium Cation (120 mg) Ferrous Cation (27 mg) Iodide Ion (150 ug) Magnesium Cation (30 ug) Zinc Cation (15 ug) Cupric Cation (2 mg)
Inactive Ingredients
Calcium Phosphate, Dibasic, Anhydrous Cellulose, Microcrystalline Stearic Acid Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 320 Shape: oval Color: white Size: 20 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 1990-10-01

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.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Indications and Usage

INDICATIONS: PNV-Select 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: One tablet daily or as directed by a physician.

Dosage Forms and Strengths

HOW SUPPLIED: PNV-Select is supplied in child-resistant bottles of 90 tablets (42192-320-90). The listed product is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Contraindications

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

Description

DESCRIPTION: PNV-Select is a prescription prenatal dietary supplement tablet that contains multivitamins and minerals, which are delivered in the form of a white, oval, oil-and water-soluble, film-coated tablet debossed with “320” 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 44425-7

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 Film Coated Tablets

NDC 42192-320-90

PNV-Select

Prenatal Multivitamin

Dietary Supplement

Film Coated Tablets

Rx Only 90 Tablets

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.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Indications and Usage (34067-9)

INDICATIONS: PNV-Select 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: One tablet daily or as directed by a physician.

Dosage Forms and Strengths (34069-5)

HOW SUPPLIED: PNV-Select is supplied in child-resistant bottles of 90 tablets (42192-320-90). The listed product is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Contraindications (34070-3)

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

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-Select is a prescription prenatal dietary supplement tablet that contains multivitamins and minerals, which are delivered in the form of a white, oval, oil-and water-soluble, film-coated tablet debossed with “320” 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 44425-7 (44425-7)

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 Film Coated Tablets (PRINCIPAL DISPLAY PANEL - Film Coated Tablets)

NDC 42192-320-90

PNV-Select

Prenatal Multivitamin

Dietary Supplement

Film Coated Tablets

Rx Only 90 Tablets

Acella

PHARMACEUTICALS, LLC


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)