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

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

Drug Label Information

Updated August 20, 2015

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

  • STATEMENT OF IDENTITY:

    Thrivite Rx is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

  • 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.

  • DOSAGE AND ADMINISTRATION:

    One tablet daily, or as prescribed by a physician.

    Supplement Facts

    Servings per Bottle: 90 Serving Size: 1 Tablet

    Each Tablet %DV Adults and Children contains 4 Years or More

    Folic Acid 1 mg 250%

    Vitamin A (beta carotene) 4000 IU 80%

    Vitamin D3 (cholecalciferol) 400 IU 100%

    Vitamin E

    (dl-alpha-tocopheryl acetate) 30 IU 100%

    Vitamin C (ascorbic acid) 120 mg 200%

    Vitamin B1 (thiamine mononitrate) 3 mg 200%

    Vitamin B2 (riboflavin) 3 mg 177%

    Niacin (niacinamide) 20 mg 100%

    Vitamin B6 (pyridoxine HCl) 3 mg 150%

    Vitamin B12 (cyanocobalamin) 8 mcg 133%

    Biotin 30 mcg 10%

    Pantothenic Acid (calcium pantothenate) 7 mg 70%

    Calcium (calcium carbonate) 200 mg 20%

    Iodine (potassium iodide) 150 mcg 100%

    Zinc (zinc oxide) 15 mg 100%

    Magnesium (magnesium oxide) 100 mg 25%

    Iron (carbonyl iron) 29 mg 161%

    Copper (cupric oxide) 3 mg 150%

    ALSO CONTAINS: Microcrystalline Cellulose, Pregelatinized Starch, Hypromellose, Titanium Dioxide, Polyvinyl Alcohol, Polyethylene Glycol, Talc, Croscarmellose Sodium, Magnesium Stearate, Stearic Acid, Fumed Silica.

    HOW SUPPLIED: Thrivite Rx is supplied as an oval, white tablet with "M133" debossed on one side. Thrivite Rx is dispensed in bottles of 90 tablets.

  • PRECAUTIONS/WARNING:

    PRECAUTIONS

    General: Folic acid, when prescribed as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.

    STORAGE: Store at 20°-25° C (68°-77° F). Excursions permitted to 15°-30° C (59°-86° F). [See USP Controlled

    Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.

  • HEALTH CLAIMS:

    Prescription Vitamin B9 Containing Dietary Supplement

  • PRINCIPAL DISPLAY PANEL

    NDC 58657-133-90
    Thrivite Rx
    Tablets

    Rx

    9
    0 Tablets

    PRINCIPAL DISPLAY PANEL
NDC 58657-133-90
Thrivite Rx
Tablets
Rx
90 Tablets

  • INGREDIENTS AND APPEARANCE
    THRIVITE RX 
    folic acid, .beta.-carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, potassium iodide, zinc oxide, magnesium oxide, iron and cupric oxide tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:58657-133
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE4000 [iU]
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    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
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN8 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID7 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE200 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE150 ug
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE100 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON29 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION3 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:58657-133-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT08/20/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    imprint
    scoring1
    shape
    size (solid drugs)19 mm
    Labeler - Method Pharmaceuticals, LLC (060216698)