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
- NHRIC Code(s): 58657-136-01
- Packager: Method Pharmaceuticals, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated August 1, 2015
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- STATEMENT OF IDENTITY:
- WARNING:
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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.
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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:
- PRINCIPAL DISPLAY PANEL
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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, coatedProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:58657-136 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 1000 [iU] ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 30 [iU] THIAMINE (UNII: X66NSO3N35) (Thiamine ION - UNII:4ABT0J945J) THIAMINE 3 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 15 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 20 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 7 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 29 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 25 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:58657-136-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 06/15/2015 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color imprint scoring 1 shape size (solid drugs) 19 mm Labeler - Method Pharmaceuticals, LLC (060216698)