PNV-Select
Acella Pharmaceuticals, LLC
Acella Pharmaceuticals, LLC
PNV-Select
FULL PRESCRIBING INFORMATION: CONTENTS*
- PNV-SELECT DESCRIPTION:
- INDICATIONS:
- PNV-SELECT CONTRAINDICATIONS:
- PRECAUTIONS:
- PNV-SELECT ADVERSE REACTIONS:
- PNV-SELECT DOSAGE AND ADMINISTRATION:
- HOW SUPPLIED:
- PRINCIPAL DISPLAY PANEL - Film Coated Tablets
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™ (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-SelectVITAMIN 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
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