Label: CAFFEINE tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 20, 2024

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  • Drug Facts

    Active ingredient (in each tablet)

    Caffeine 200mg


  • 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)
    • avoid excessive heat (greater than 100°F) or humidity
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, corn starch, titanium dioxide

  • Questions or comments?

    Call 1-855-274-4122
    Distributed by:
    Aurohealth LLC.
    279 Princeton-Hightstown Road,
    East Windsor, NJ 08520

    Made in India

    Code: TS/DRUGS/16/2014

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 200 mg (40 Tablets Blister Carton)

    AUROHEALTH

    NDC 58602-747-47

    Compare to the active
    ingredient in Vivarin®*

    CAFFEINE TABLETS 200 mg
    ALERTNESS AID

    EQUAL TO ABOUT
    A CUP OF COFFEE
    40 Tablets/200 mg Each
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 200 mg (16 Tablets Container Carton)

  • INGREDIENTS AND APPEARANCE
    CAFFEINE 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-747
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUND (Biconvex) Size11mm
    FlavorImprint Code C5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-747-475 in 1 CARTON07/04/2024
    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 DrugM01107/04/2024
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(58602-747) , MANUFACTURE(58602-747)
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