UDAMIN SP (VITAMIN E, VITAMIN B6, FOLIC ACID, VITAMIN B12, ZINC, SELENIUM, SAW PALMETTO, TOCOPHEROLS AND LYCOPENE COMPLEX) CAPSULE, COATED [POLY PHARMACEUTICALS, INC.]

UDAMIN SP (VITAMIN E, VITAMIN B6, FOLIC ACID, VITAMIN B12, ZINC, SELENIUM, SAW PALMETTO, TOCOPHEROLS AND LYCOPENE COMPLEX) CAPSULE, COATED [POLY PHARMACEUTICALS, INC.]
PDF | XML

NDC 50991-231-01
Set ID 8a995199-e1f0-492d-988f-78dfba5810a4
Category DIETARY SUPPLEMENT
Packager Poly Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number
  • STATEMENT OF IDENTITY: 

    UDAMIN SP caplets for oral administration is a 90-day dietary supplement that consists of 100 white film-coated, capsule shaped tablet each debossed with “PE820”.

  • WARNING:

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

  • SAFE HANDLING WARNING: 

    Keep this product out of reach of children.  In case of accidental overdose, call a doctor or poison control center immediately.

  • DOSAGE AND ADMINISTRATION: 

    Adults: One caplet twice daily, or as directed by a physician. UDAMIN SP is not recommended for women or adolescents.

    Supplement Facts
    Serving Size 1 Caplet  Servings Per Container 100
    Each White, Film-coated Capsule Shaped Tablet (caplet) for Oral Administration Contains)
    Vitamin E
    (as d-alpha tocopheryl acid succinate from soy) ..............75 IU
    Vitamin B6
    (as pyridoxine HCL) ......................................................12.5 mg
    Folic Acid ................................................................... 1000 mcg
    Vitamin B12
    (as cyanocobalamin) ....................................................250 mcg
    Zinc
    (as zinc gluconate) .........................................................7.5 mg
    Selenium
    (as selenium chelate) ...................................................100 mcg
    Saw Palmetto Extract ...................................................320 mg*
    Other tocopherols:
    (d-gamma, d-delta, d-beta) ..............................................17 mg
    Lycopene Complex ..........................................................2.5 mg
    *Yielding 144 mg of active ingredients, including free fatty acids.

    OTHER INGREDIENTS: Each caplet also contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate, cellulose, calcium silicate, rice protein, partially pregelatinized maize starch, silica, stearic acid, maltodextrin, sodium croscarmellose, magnesium stearate, gelatin (poultry), sucrose, corn starch, sodium selenite, ascorbyl palmitate, sodium ascorbate, Dl-alpha tocopherol. Coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc.

    HOW SUPPLIED: White film-coated, capsule shaped tablet—supplied in bottles of 100. Debossed with “PE820”. Store at controlled room temperature between 15°-30°C (59°-86°F).

    Dispense in a tight, light resistant container as defined in the USP/NF with a child-resistant closure. NDC#50991-0231-01, 100 caplets per bottle. The listed product number is not a National Drug Code. Instead, Poly Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and health insurance computer systems.

  • PRECAUTIONS/WARNING:

    Folic acids in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 250 mcg of Vitamin B12 (as cyanocobalamin) contained in each caplet of UDAMIN SP should address this precaution.

    Adverse Reactions

    Allergic sensitization has been reported following both oral and parental administration of folic acid. Paresthesia, somnolence have been reported with pyridoxine HCl.

    Drug Interactions

    Pyridoxine daily can decrease the efficacy of levodopa in the treatment of Parkinsonism. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness.

    STORAGE: Store controlled room temperature, 15°- 30°C (59°- 86°F)

  • HEALTH CLAIMS:

    Because toxic reactions have been reported with injudicious use of certain vitamins and minerals, patients should be instructed to follow physician’s dosage regimen.

    ALLERGEN STATEMENT: This product contains soy.

    CONTRAINDICATIONS: UDAMIN SP is contraindicated in patients with a known hypersensitivity to any of its ingredients.

     

  • PRINCIPAL DISPLAY PANEL

    100 Caplets container label

    50991-231-01       RX ONLY

    Udamin SP

    DIETARY SUPPLEMENT

    Manufactured For:
    Poly Pharmaceuticals, Inc
    Mobile, AL 36119

    Protected by U.S. Patent #'s 7,002,350;7,186,421; and 7,390,511

    Revised 07/11                                                       8838

    NDC 50991-0231-01
Udamin SP
100 Caplets
Dietary Supplement
Rx Only

  • INGREDIENTS AND APPEARANCE
    UDAMIN SP 
    vitamin e, vitamin b6, folic acid, vitamin b12, zinc, selenium, saw palmetto, tocopherols and lycopene complex capsule, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:50991-231
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL75 [iU]
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE12.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN250 ug
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC7.5 mg
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM100 ug
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO320 mg
    TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL17 mg
    LYCOPENE (UNII: SB0N2N0WV6) (LYCOPENE - UNII:SB0N2N0WV6) LYCOPENE2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: 701EKV9RMN)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM SELENITE (UNII: HIW548RQ3W)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:50991-231-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT07/01/2011
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    imprint
    scoring1
    shape
    size (solid drugs)23 mm
    Labeler - Poly Pharmaceuticals, Inc. (198449894)

Related Drugs