Label: CAFFEINE tablet

  • NDC Code(s): 69842-509-10, 69842-509-21, 69842-509-31
  • Packager: CVS Pharmacy, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 September 23, 2020

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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

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

    Do not use

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

    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

    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 and over: take 1 tablet not more often than every 3 to 4 hours

  • Other information

    ■ each tablet contains: calcium 62 mg

    ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    ■ see end flap for expiration date and lot number

  • Inactive ingredients

    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

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    © 2018 CVS/pharmacy

    CVS.com®

    1-800-SHOP CVS

    V-34571

  • PRINCIPAL DISPLAY PANEL


    CVS Health

    Compare to the active ingredient in Vivarin®*

    Caffeine Tablets

    Caffeine,200mg

    Alertness aid

    • For mental alertness

    • Safe & effective

    80 Tablets

    CVS label

  • INGREDIENTS AND APPEARANCE
    CAFFEINE 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-509
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 212;212
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-509-105 in 1 CARTON06/22/2018
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69842-509-212 in 1 CARTON06/22/2018
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:69842-509-311 in 1 CARTON06/22/2018
    380 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34006/22/2018
    Labeler - CVS Pharmacy, Inc. (062312574)
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