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 
Method Pharmaceuticals, LLC

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Thrivite Rx

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

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)

Revised: 8/2015
Document Id: 9d41b96b-e6ba-448f-aae8-5f4f430c2e4b
Set id: 55c36f59-816f-430a-9ec0-f6641e91073c
Version: 1
Effective Time: 20150820
 
Method Pharmaceuticals, LLC