Label: CAFFEINE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 17, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • 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 (063997360)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!