Label: NIACIN capsule, extended release

  • NHRIC Code(s): 49483-018-01, 49483-018-00
  • Packager: TIME CAP LABS INC
  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated April 4, 2014

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  • STATEMENT OF IDENTITY

    Niacin Dietary Supplement Extended Release Capsules 500 mg

  • WARNINGS

    Do not use this product if you have a known sensitivity or allergy to niacin. Use only under the advice and supervision of a physician if you:have heart disease, abnormal chest pain (angina)or recently suffered a heart attack; are taking high blood pressure or cholestrol lowering drugs(because of possible drug interactions); have any of the following conditions: gallbladder disease, gout, arterial bleeding, diabetes, imparied liver function, peptic ulcer, or are a pregnant or lactating woman.

  • SAFE HANDLING WARNING

    Keep out of Reach of children.  If you are pregnant or nursing a baby, seek the advice of a health professinoal before using this product

  • HEALTH CLAIM

    DIETARY SUPPLEMENT

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    NIACIN 
    niacin capsule, extended release
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:49483-018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SHELLAC (UNII: 46N107B71O)  
    GELATIN (UNII: 2G86QN327L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:49483-018-01100 in 1 BOTTLE, PLASTIC
    2NHRIC:49483-018-00100000 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement04/04/2014
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)7 mm
    scoring1
    Labeler - TIME CAP LABS INC (037052099)
    Registrant - TIME CAP LABS INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABS INC037052099manufacture(49483-018)
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