Label: PNV TABS 29-1- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, potassium iodide, magnesium oxide, zinc oxide, and cupric oxide tablet

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated September 28, 2018

If you are a consumer or patient please visit this version.

  • HEALTH CLAIM

    69543-267-90
    Rx

     
    Prenatal/Postnatal
    Prescription Folic Acid-Containing Dietary Supplement
  • DESCRIPTION

    PNV Tabs 29-1 is a prescription oral dietary supplement and should be administered under the supervision of a licensed medical practitioner.

    Supplement Facts Table
    Serving Size: 1 Tablet
    Amount Per Serving% Daily Value* for Pregnant &
    Lactating Women
    *
    The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

    Vitamin A (beta carotene)

    600 mcg RAE

    46 %

    Vitamin C (ascorbic acid)

    120 mg

    100 %

    Vitamin D (Vitamin D3 as cholecalciferol)

    10 mcg (400 IU)

    67 %

    Vitamin E (dl-alpha-tocopheryl acetate)

    27 mg

    142 %

    Thiamin (Vitamin B1 as thiamine mononitrate)

    3 mg

    214 %

    Riboflavin (Vitamin B2)

    3 mg

    188 %

    Niacin (niacinamide)

    20 mg NE

    111 %

    Vitamin B6 (pyridoxine HCl)

    3 mg

    150 %

    Folate

    1667 mcg DFE
    (1 mg folic acid)

    278 %

    Vitamin B12 (cyanocobalamin)

    8 mcg

    286 %

    Biotin

    30 mcg

    86 %

    Pantothenic Acid (calcium pantothenate)

    7 mg

    100 %

    Calcium (calcium carbonate)

    200 mg

    15 %

    Iron (carbonyl iron)

    29 mg

    107 %

    Iodine (potassium iodide)

    150 mcg

    52 %

    Magnesium (magnesium oxide)

    100 mg

    25 %

    Zinc (zinc oxide)

    15 mg

    115 %

    Copper (cupric oxide)

    3 mg

    231 %

    Other Ingredients: Microcrystalline Cellulose, Stearic Acid, Coating (Hypromellose, Polydextrose, Titanium Dioxide, Polyethylene Glycol), Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate.

  • ALLERGY STATEMENT

    This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion.

  • PHARMACOLOGY

    Adequate Folate in healthful diets may reduce a woman's risk of having a child with a brain or spinal cord defect.1

  • SIDE EFFECTS2

    Side effects are uncommon with folic acid, thiamine, riboflavin, pyridoxine, iron, and copper.

    Gastrointestinal side effects including anorexia, nausea, abdominal distention, flatulence, and bitter taste are rarely seen with folic acid and pyridoxine. Gastrointestinal side effects due to iron include nausea, constipation, anorexia, heartburn, vomiting, and diarrhea.

    Hypersensitivity reactions due to folic, thiamine, or pyridoxine have been seen rarely.

  • PATIENT INFORMATION

    This product is a dietary management prescription folate supplement to be used only under licensed medical supervision. Consult a medical practitioner before use with medications.

    KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.

  • INTERACTIONS2

    Folic acid has major interactions with fluorouracil and its prodrugs, for example capecitabine. Use of this product with patients who are taking fluorouracil drugs should be undertaken only with extreme caution under the direction of a licensed medical practitioner.

    Folic acid also interacts moderately with antiepileptic drugs, monoamines (e.g. levodopa, serotonin) and drugs that interfere with homocysteine metabolism.

    Drugs known to interfere with folic acid absorption from the intestine include cholestyramine, colestipol, and cyclosporine.

    Drugs which may interact moderately with vitamin B12 include arsenic and chloramphenicol.

    Carbonyl iron has major interactions with abacavir/dolutegravir and lamivudine, dimercaprol and dolutegravir.

    Vitamin C (ascorbic acid) interacts moderately with amphetamines and the antineoplastic drug bortezomib.

  • CONTRAINDICATIONS

    This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated.

  • WARNINGS

    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 immediately3.

  • DIRECTIONS FOR USE

    One tablet daily with or without food or as prescribed by a licensed medical practitioner, regardless of lactation status.

  • REFERENCES

    1.
    21 CFR §101.79(d)(1)(ii)
    2.
    All side effects and drug information was obtained from www.drugs.com
    3.
    21 CFR 101.17(e)(1)
  • PREGNANCY and NURSING MOTHERS

    Use of PNV Tabs 29-1 with products containing folic acid is not recommended, as this will result in folic acid intake that exceeds the daily upper limit.

  • STORAGE

    Store at controlled room temperature 15° to 30°C (59° to 86°F). Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

  • HOW SUPPLIED

    PNV Tabs 29-1 are supplied as oval, white tablets debossed on one side with "V267" dispensed in child-resistant bottles of 90 tablets.

    Call your medical practitioner about side effects. You may report side effects by calling Virtus at 1-888-848-3593.

    Rx

    Manufactured for:
    Virtus Pharmaceuticals, LLC.
    Langhorne, PA 19047

    MADE IN USA

    Rev. 09/2018

  • PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

    90 Tablet Bottle Label

    VIRTUS®
    PHARMACEUTICALS

    69543-267-90

    PNV Tabs 29-1

    PRENATAL/POSTNATAL

    Prescription Folic Acid-Containing
    Dietary Supplement

    Rx

    90 Tablets

    Made in the USA

  • INGREDIENTS AND APPEARANCE
    PNV TABS 29-1 
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, potassium iodide, magnesium oxide, zinc oxide, and cupric oxide tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69543-267
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .Beta.-carotene (UNII: 01YAE03M7J) (.Beta.-carotene - UNII:01YAE03M7J) .Beta.-carotene4000 [iU]
    Ascorbic acid (UNII: PQ6CK8PD0R) (Ascorbic acid - UNII:PQ6CK8PD0R) Ascorbic acid120 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
    .Alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.Alpha.-tocopherol, dl- - UNII:7QWA1RIO01) .Alpha.-tocopherol, dl-30 [iU]
    Thiamine mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine3 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin3 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
    Pyridoxine hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine hydrochloride3 mg
    Folic acid (UNII: 935E97BOY8) (Folic acid - UNII:935E97BOY8) Folic acid1 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin8 ug
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin30 ug
    Calcium pantothenate (UNII: 568ET80C3D) (Pantothenic acid - UNII:19F5HK2737, Calcium cation - UNII:2M83C4R6ZB) Pantothenic acid7 mg
    Calcium carbonate (UNII: H0G9379FGK) (Calcium cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) Calcium carbonate200 mg
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron29 mg
    Potassium iodide (UNII: 1C4QK22F9J) (Iodide ion - UNII:09G4I6V86Q) Potassium iodide150 ug
    Magnesium oxide (UNII: 3A3U0GI71G) (Magnesium cation - UNII:T6V3LHY838) Magnesium oxide100 mg
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide15 mg
    Cupric oxide (UNII: V1XJQ704R4) (Cupric cation - UNII:8CBV67279L) Cupric cation3 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69543-267-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement07/16/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    size (solid drugs)19 mm
    shape
    scoring1
    imprint
    Labeler - Virtus Pharmaceuticals (079659493)