VIVARIN (CAFFEINE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]

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VIVARIN (CAFFEINE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]
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NDC 67751-160-01, 67751-160-02
Set ID 5e34ae97-d5e7-4c70-8dec-e0be462bea55
Category HUMAN OTC DRUG LABEL
Packager Navajo Manufacturing Company Inc.
Generic Name
Product Class
Product Number
Application Number PART340
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  • Drug Facts

  • Active ingredient (in each tablet)

    Caffeine 200mg

    Purpose

    Alertness Aid

  • Use

    helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

  • Warnings

    For occasional use only

    Do not use

    • in children under 12 years
    • as a substitute for sleep

    When using this product

    limit the use of caffeine containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

    Stop use and ask a doctor if

    fatigue or drowsiness persists or continues to recur.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours

  • Other information

    • each tablet contains calcium 65 mg
    • store at room temperature 20°-25°C (68°-77°F)
    • avoid excessive heat (greater than 100°F) or humidity
    • do not use if pouch is opened or torn
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • Questions or comments?

    Call toll-free 1-855-874-0970 8:30am to 5:00pm EST Monday to Friday

  • Package Labeling

    Vivarin

  • INGREDIENTS AND APPEARANCE
    VIVARIN 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-160(NDC:46017-018)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-160-011 in 1 CARTON09/21/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67751-160-021 in 1 CARTON09/21/2016
    24 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34009/21/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-160) , repack(67751-160)
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