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
Acella Pharmaceuticals, LLC

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.

Rx Only

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.

table
(click image for full-size original)

OTHER INGREDIENTS: Dicalcium Phosphate, Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Film Coating (Hydroxy Propyl Methyl Cellulose, Triacetin, 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 (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.

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. 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 dietary ingredients, other ingredients and information provided herein.

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

MANUFACTURED FOR:

Acella Pharmaceuticals, LLC

Alpharetta, GA 30005

1-800-541-4802

Rev 0719-03

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

PNV- Select
(click image for full-size original)
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 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 (VITAMIN A) VITAMIN A 2500 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 80 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
BIOTIN (BIOTIN) BIOTIN 300 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 6 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 120 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 150 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 30 ug
ZINC OXIDE (ZINC CATION) ZINC CATION 15 ug
CUPRIC OXIDE (CUPRIC CATION) 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 white Score no score
Shape OVAL Size 20mm
Flavor Imprint Code 320
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42192-320-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/1990
Labeler — Acella Pharmaceuticals, LLC (825380939)
Registrant — Acella Pharmaceuticals, LLC (825380939)
Establishment
Name Address ID/FEI Operations
Acella Pharmaceuticals, LLC 825380939 manufacture (42192-320)

Revised: 01/2020 Acella Pharmaceuticals, LLC

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