Label: VIVA CT PRENATAL- folic acid, ferrous fumarate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, zinc oxide, cupric sulfate anhydrous, and selenomethionine tablet, chewable

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 3, 2012

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    30ct round, light pink to pink-colored, fruit-flavored chewable tablets, embossed VCT

    Prescription PRENATAL/POSTNATAL Vitamin

  • DESCRIPTION

    Viva® CT Prenatal Chewable is an orally administered, chewable prescription PRENATAL/POSTNATAL vitamin specifically formulated for the dietary management of individuals with unique nutritional needs requiring increased folate levels. Viva® CT Prenatal Chewable should be administered under the supervision of a licensed medical practitioner.

    Each ROUND, LIGHT TO PINK-colored, chewable tablet contains the following dietary ingredients:

    *
    Daily Value not established for individuals with unique nutritional needs who are in need of nutritional supplementation as directed by a licensed medical practitioner.
    †
    L-(+)-Selenomethionine as Selenium SeLECT® is a registered trademark of Sabinsa Corporation, Piscataway, NJ. It has CAS #3211-76-5, and is chemically known as the diasterioisomerically pure (S)-(+)-2-Amino-4(methylseleno)-butanoic acid.
    Folic Acid1 mg*
    Iron (ferrous fumarate)28 mg*
    Vitamin C (ascorbic acid)100 mg*
    Vitamin D3 (cholecalciferol)400 IU*
    Vitamin E (acetate)30 IU*
    Vitamin B1 (thiamine mononitrate)3 mg*
    Vitamin B2 (riboflavin)3 mg*
    Vitamin B6 (pyridoxine HCl)50 mg*
    Vitamin B12 (cyanocobalamin)15 mcg*
    Zinc (oxide)20 mg*
    Copper (sulfate)1 mg*
    L-(+)-Selenomethionine†50 mcg*

    Other Ingredients

    Xylitol, Microcrystalline Cellulose, Povidone, Magnesium Stearate, Talc, Fruit Punch Flavor, Sucralose.

  • FOLATE REGULATION

    The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, I-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate. Folic acid, including the reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.

    The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that: Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription. Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b) (3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).

    1
    This product is a dietary supplement that - due to increased folate levels (AUG 3 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of vitamin B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.
  • INDICATIONS AND USAGE

    Viva® CT Prenatal Chewable is indicated for the distinct nutritional requirements of individuals in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner. This product can be used fordietary management prior to conception. Viva® CT Prenatal Chewable should be administered under the supervision of a licensed medical practitioner.

  • CONTRAINDICATIONS

    Viva® CT Prenatal Chewable is contraindicated in individuals with a known hypersensitivity to any of the ingredients.

  • WARNINGS

    WARNING

    Accidental overdose of iron-containing products is the leading cause of poisoning of children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

  • PREGNANCY and NURSING MOTHERS

    Viva® CT Prenatal Chewable is intended for use as a PRENATAL/POSTNATAL vitamin for lactating and non-lactating mothers. Talk with your medical practitioner to ensure adequate prenatal/postnatal supplementation. Consult with your licensed medical practitioner before using Viva® CT Prenatal Chewable if pregnant or nursing.

  • PRECAUTIONS

    Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

    PATIENT INFORMATION

    Viva® CT Prenatal Chewable is a prescription PRENATAL/POSTNATAL vitamin to be used only under licensed medical supervision.

    DRUG INTERACTIONS

    Drugs which may interact with folate include:

    • Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate.
    • Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among individuals who are receiving treatment with phenytoin and other anticonvulsants.
    • Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
    • Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
    • Colestipol: Reduces folic acid absorption and reduces serum folate levels.
    • Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
    • Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
    • Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
    • Isotretinoin: Reduced folate levels have occurred in some individuals taking isotretinoin.
    • L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels.
    • Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments.
    • NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
    • Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
    • Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
    • Pancreatic Enzymes: Reduced folate levels have occurred in some individuals taking pancreatic extracts, such as pancreatin and pancrelipase.
    • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
    • Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.
    • Smoking and Alcohol: Reduced serum folate levels have been noted.
    • Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
    • Metformin treatment in individuals with type 2 diabetes decreases serum folate.
    • Warfarin can produce significant impairment in folate status after a 6-month therapy.
    • Heme-iron: Can compete for transport and reduce folate absorption. Ensure adequate medical supervision to ensure proper iron levels.
    • Folinic acid may enhance the toxicity of fluorouracil.
    • Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate.
    • Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.

    **Folate is a broad term that includes folic acid and all reduced forms including I-methylfolate and folinic acid. Viva® CT Prenatal Chewable does not contain I-methylfolate or folinic acid but these warnings are included as general folate information.

    Drugs which interact with vitamin B6:

    • Vitamin B6 should not be given to individuals receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in individuals receiving a preparation containing both carbidopa and levodopa.

    Drugs which may interact with vitamin B12:

    • Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12.
    • Nitrous oxide can produce a functional vitamin B12 deficiency.
  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folate. Paresthesia, somnolence, nausea, and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.

  • DOSAGE AND ADMINISTRATION

    Chew and swallow one tablet daily, or as directed by a licensed medical practitioner.

  • STORAGE

    Store at Controlled Room Temperature 15°- 30°C (59°- 86°F). [See USP]. Dispense in a tight, light-resistant container.

  • HOW SUPPLIED

    Viva® CT Prenatal Chewable is supplied as round, light pink to pink-colored chewable tablets embossed VCT, and are dispensed in bottles of 30 tablets.

    NDC1 64661-811-30

  • SPL UNCLASSIFIED SECTION

    Call your medical practitioner about side effects. You may report side effects by calling 866-280-5961.

    KEEP THIS OUT OF REACH OF CHILDREN.

    Rx Only

    All prescriptions using this product shall be pursuant to State statutes as applicable.

    Manufactured by: Sancilio & Company, Inc.,
    3874 Fiscal Court, Suite 200, Riviera Beach, FL 33404

    JAYMAC
    Pharmaceuticals, LLC

    MADE IN CHINA

    REV 4/2012

  • PRINCIPAL DISPLAY PANEL - 30 Chewable Tablet Label

    Rx
    Patent Protected

    30 ct. Fruit-flavored,
    Chewable Tablets

    Viva®CT
    Prenatal Chewable

    Manufactured for:
    JAYMAC
    Pharmaceuticals, LLC

    Sunset, LA 70584

    Prescription Vitamin
    NDC++64661-811-30

    PRINCIPAL DISPLAY PANEL - 30 Chewable Tablet Label
  • INGREDIENTS AND APPEARANCE
    VIVA CT   PRENATAL
    folic acid, ferrous fumarate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, zinc oxide, cupric sulfate anhydrous, and selenomethionine tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64661-811
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7) FERROUS FUMARATE28 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE30 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN15 ug
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 mg
    CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV) (COPPER - UNII:789U1901C5) CUPRIC SULFATE ANHYDROUS1 mg
    Selenomethionine (UNII: 964MRK2PEL) (Selenomethionine - UNII:964MRK2PEL) Selenomethionine50 ug
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINK (light pink to pink) Scoreno score
    ShapeROUNDSize8mm
    FlavorFRUIT PUNCHImprint Code VCT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64661-811-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER05/01/2012
    Labeler - JayMac Pharmaceuticals LLC (830767260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sancilio176681257MANUFACTURE
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