Label: VALUMEDS MAXIMUM STRENGTH STAY AWAKE- caffeine 200 mg tablets tablet

  • NDC Code(s): 68210-0403-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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  • Drug Facts

    Active ingredient (in each tablet)                                                                  
    Caffeine 200 mg

  • Purpose

    Alertness Aid

  • INDICATIONS & USAGE

    Use

    ■ helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

  • WARNINGS

    Warnings

    For occasional use only

    Do not use

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

  • WHEN USING

    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

    Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

  • DOSAGE & ADMINISTRATION

    Directions

    ■ adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.

  • SPL UNCLASSIFIED SECTION

    Other information

    ■ store at room temperature
    ■ avoid excessive heat (greater than 100°F) or humidity

  • INACTIVE INGREDIENT

    Carnuba wax, colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrates,
    FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline
    cellulose, polyethylene glycol, titanium dioxide

  • QUESTIONS

    Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    VALUMEDS


    MAXIMUM STRENGTH
    STAY AWAKE

    Caffeine 200 mg


    safe and effective


    250 tablets

    Label

  • INGREDIENTS AND APPEARANCE
    VALUMEDS MAXIMUM STRENGTH STAY AWAKE 
    caffeine 200 mg tablets tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize1mm
    FlavorImprint Code AZ076
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0403-1250 in 1 BOTTLE; Type 0: Not a Combination Product08/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01108/06/2019
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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