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 July 18, 2022

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  • Drug Facts

    Active ingredient (in each tablet)
    Caffeine 200 mg

  • PURPOSE

    Purpose
    Alertness aid

  • Use

    helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

  • WARNINGS

    Do not use
    ■ as a substitute for sleep. This product is intended for occasional use only.
    ■ in children under 12 years of age

    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 60 mg
    ■ store in a dry place at 15° – 30°C (59° – 86°F)
    ■ do not use if imprinted seal under cap is broken or missing

  • INACTIVE INGREDIENT

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

  • Questions or comments?


    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    WALGREEN CO.
    200 WILMOT ROAD
    DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL

    Walgreens

    Compare to Vivarin® active ingredient††

    Stay Awake

    CAFFEINE 200 mg /
    ALERTNESS AID

    Maximum Strength

    • Caffeine for mental alertness
    • Equal to about a cup of coffee

    100 Tablets

    walgreen label

  • INGREDIENTS AND APPEARANCE
    CAFFEINE 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 212;212
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5009-011 in 1 CARTON09/28/2021
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34009/28/2021
    Labeler - Walgreen Company (008965063)
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