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 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 of age

    ■ 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.

    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 1/2 to 1 tablet not more often than every 3 to 4 hours

  • Other Information

    ■ each tablet contains: calcium 63 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 INGREDIENT

    corn starch, croscarmellose sodium, dicalcium phosphate, 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

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    *This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Maximum Strength NoDoz®.

    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

    CVSHealth

    Compare to the active ingredient in Maximum Strength NoDoz®*

    MAXIMUM STRENGTH

    Caffeine Tablets

    CAFFEINE, 200 mg

    Alertness aid

    • Easy to swallow

    • Fast acting

    • Safe & ef fective

    60 TABLETS

    CVS Label

  • INGREDIENTS AND APPEARANCE
    CAFFEINE 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-500
    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)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 212;212
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-500-111 in 1 CARTON06/28/2018
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34006/28/2018
    Labeler - CVS Pharmacy, Inc. (062312574)
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