Label: THRIVITE 19- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium tablet, coated

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

Drug Label Information

Updated August 1, 2015

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

  • STATEMENT OF IDENTITY:

    Thrivite 19 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 or two tablets daily, in divided doses, or as directed by a physician.

    Each tablet contains:

    Vitamin A (as beta carotene) ................................................. 1000 IU

    Vitamin C (ascorbic acid) ........................................................ 100 mg

    Vitamin D (as cholecalciferol) .................................................. 400 IU

    Vitamin E (as dl-alpha tocopheryl acetate) ................................. 30 IU

    Thiamine (Vitamin B1) ............................................................... 3 mg

    Riboflavin (Vitamin B2) ............................................................... 3 mg

    Niacin (as niacinamide) ........................................................... 15 mg

    Vitamin B6 (as pyridoxine HCI) ................................................ 20 mg

    Folate (folic acid) ...................................................................... 1 mg

    Vitamin B12 (as cyanocobalamin) ............................................ 12 mcg

    Pantothenic Acid (as calcium pantothenate) ................................ 7 mg

    Calcium (as calcium carbonate) .............................................. 200 mg

    Iron (as ferrous fumarate) ....................................................... 29 mg

    Zinc (as zinc oxide) .................................................................. 20 mg

    Docusate Sodium ..................................................................... 25 mg 

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

    HOW SUPPLIED:

    Thrivite 19 tablets for oral administration are supplied as white, coated, oblong tablets debossed "M136", packaged in bottles of 100 tablets.

  • PRECAUTIONS/WARNING: 

    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 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

    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 58657-136-01
    Thrivite 19
    Tablets

    Rx

    100 Tablets

    PRINCIPAL DISPLAY PANEL
NDC 58657-136-01
Thrivite 19
Tablets
Rx
100 Tablets

  • INGREDIENTS AND APPEARANCE
    THRIVITE 19 
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium tablet, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:58657-136
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE1000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 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 (UNII: X66NSO3N35) (Thiamine ION - UNII:4ABT0J945J) THIAMINE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE15 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE20 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID7 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM25 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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ACACIA (UNII: 5C5403N26O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:58657-136-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT06/15/2015
    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)