CAFFEINE TABLET [CARDINAL HEALTH]

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CAFFEINE TABLET [CARDINAL HEALTH]
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NDC 70000-0409-1
Set ID 7c4d61f7-9c6a-61ac-e053-2991aa0a9533
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number PART340
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  • Drug Facts

    Active ingredient (in each tablet)

    Caffeine 200 mg

  • PURPOSE

    Purpose

    Alertness aid

  • Uses

    helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

  • WARNINGS

    For occasional use only

    Do not use

    ■ in children under 12 years of age

    ■ 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 (1-800-222-1222) right away.

  • Directions

    ■ adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours

  • Other information

    ■ each tablet contains: calcium 62 mg

    ■ store at room temperature 20-25°C (68°-77°F)

    ■ avoid excessive heat (greater than 100°F) or humidity

  • INACTIVE INGREDIENT

    corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by Meda Consumer Healthcare Inc., owner of the registered trademark Vivarin®.

    Dist. by CAH, Dublin, OH 43017

    ©2019 Cardinal Health

    100% Money Back Guarantee

    Return to place of purchase if not satisfied

  • PRINCIPAL DISPLAY PANEL

    Leader

    NDC 70000-0409-1

    Caffeine Tablets

    Caffeine, 200mg/ Alertness Aid

    For Mental Alertness

    Safe & Effective

    COMPARE TO VIVARIN® active ingredient*

    100% Money Back Guarantee

    16 Tablets

    5009-cardinal-label

  • INGREDIENTS AND APPEARANCE
    CAFFEINE 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0409
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 212;212
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0409-12 in 1 CARTON04/05/2019
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34004/05/2019
    Labeler - Cardinal Health (097537435)
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