AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]

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AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]
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NDC 36800-844-11
Set ID e8961b01-d692-40e7-a52f-2d81a21f06c5
Category HUMAN OTC DRUG LABEL
Packager Topco Associates, LLC
Generic Name
Product Class
Product Number
Application Number PART340
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  • Active ingredient (in each caplet)

    Caffeine 200 mg

  • Purpose

    Alertness aid

  • Use

    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 heart beat.

    Do not use

    • for 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 right away.

  • Directions

    • adults and children 12 years and over: take ½ to 1 caplet not more often than every 3 to 4 hours
    • children under 12 years: do not use
  • Other information

    • 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, dextrates hydrated, dibasic calcium phosphate dihydrate, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid

  • Questions or comments?

    1-888-423-0139

  • Principal display panel

    TopCare®
    health

    NDC 36800-844-11

    COMPARE TO MAXIMUM
    STRENGTH NODOZ®
    ACTIVE INGREDIENT*

    MAXIMUM STRENGTH
    Awake CAFFEINE, 200 mg
    Alertness Aid

    • Helps Restore Mental Alertness When
    Experiencing Fatigue

    60 CAPLETS

    actual
    size

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

    *This product is not manufactured or distributed by Lil’
    Drug Store Products, Inc., owner of the registered
    trademark Maximum Strength NoDoz®.
    50844               REV1219B3441

    DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007 © TOPCO LNKA0521
    QUESTIONS? 1-888-423-0139
    topcare@topco.com www.topcarebrand.com

    QUALITY
    GUARANTEED

    TopCare 44-344

    TopCare 44-344


  • INGREDIENTS AND APPEARANCE
    AWAKE  MAXIMUM STRENGTH
    caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-844
    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)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize15mm
    FlavorImprint Code 44;344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-844-111 in 1 CARTON04/14/1998
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34004/14/1998
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(36800-844)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(36800-844)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(36800-844)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(36800-844)
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