PNV-Select description, usages, side effects, indications, overdosage, supplying and lots more!

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PNV-Select

Acella Pharmaceuticals, LLC
Acella Pharmaceuticals, LLC

PNV-Select


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx Only

DESCRIPTION:

PNV-Select is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “320” on one side.

EACH TABLET CONTAINS:
Vitamin A (100% as beta-carotene) 2500 IU
Vitamin C (ascorbic acid) 80 mg
Vitamin D3 (cholecalciferol) 400 IU
Vitamin E (dl-alpha tocopherol acetate) 10 IU
Vitamin B1 (thiamine mononitrate) 3 IU
Vitamin B2 (riboflavin) 3.4 mg
Niacinamide 20 mg
Vitamin B6 (pyridoxine HCl) 20 mg
Folate (L-methylfolate as Zolafin-B™Zolafin-B™ is a trademark of Acella Pharmaceuticals, LLC 600 mcg)
(folic acid, USP 400 mcg)
1 mg
Vitamin B12 12 mcg
Biotin 300 mcg
Pantothenic acid (calcium pantothenate) 6 mg
Calcium (calcium carbonate) 120 mg
Iron (ferrous fumarate) 27 mg
Iodine (potassium iodide) 150 mcg
Magnesium (magnesium oxide) 30 mg
Zinc (zinc oxide) 15 mg
Copper (copper oxide) 2 mg

OTHER INGREDIENTS:

dicalcium phosphate, microcrystalline cellulose, stearic acid, aqueous coating, croscarmellose sodium, silica, magnesium stearate and titanium dioxide.

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.

CONTRAINDICATIONS:

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

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.

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:

One tablet daily or as directed by a physician.

HOW SUPPLIED:

PNV-Select is supplied in child-resistant bottles of 90 tablets (NDC# 42192-320-90).

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 or therapeutic equivalency. 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
1-800-541-4802 Rev. 0610v4

PRINCIPAL DISPLAY PANEL - Film Coated Tablets

NDC 42192-320-90

PNV-Select

Prenatal Multivitamin Supplement Film Coated Tablets

Rx Only         90 Tablets

Acella
PHARMACEUTICALS, LLC

PNV-Select

PNV-Select

VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE and CUPRIC OXIDE, TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:42192-320
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE 2500 [iU]
ASCORBIC ACID ASCORBIC ACID 80 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- 10 [iU]
THIAMINE MONONITRATE THIAMINE ION 3 mg
RIBOFLAVIN RIBOFLAVIN 3.4 mg
NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 20 mg
FOLIC ACID FOLIC ACID 1 mg
Cyanocobalamin CYANOCOBALAMIN 12 ug
BIOTIN 300 ug
CALCIUM PANTOTHENATE PANTOTHENIC ACID 6 mg
CALCIUM CARBONATE 120 mg
FERROUS FUMARATE FERROUS CATION 27 mg
Potassium Iodide IODIDE ION 150 ug
magnesium oxide 30 ug
Zinc Oxide Zinc oxide 15 ug
CUPRIC OXIDE CUPRIC CATION 2 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
cellulose, microcrystalline
STEARIC ACID
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 20 mm 320 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42192-320-90 90 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-11-02


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