Label: NODOZ ALERTNESS AID MAXIMUM STRENGTH- caffeine tablet, film coated

  • 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 April 20, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 heartbeat.

    Do not use

    • in children under 12 years of age
    • as 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 of age and over:
      take 1/2 to 1 caplet not more often than every 3 to 4 hours
  • Other information

    • store at controlled room temperature of 20-25°C (68-77°F)
  • Inactive ingredients

    carnauba wax, corn starch, FD&C blue #1, hypromellose, microcrystalline cellulose, povidone K30, propylene glycol, stearic acid, sucrose, titanium dioxide

  • Questions or comments?

    call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST) or www.nodoz.com

  • PRINCIPAL DISPLAY PANEL - 200 mg Caplet Pouch Carton

    Max Strength • Fast Acting

    NoDoz®

    Alertness Aid

    200 mg CAFFEINE EACH

    4
    CAPLETS
    2 POUCHES, 2 CAPLETS PER POUCH

    Lil'
    Drug Store ®

    PRINCIPAL DISPLAY PANEL - 200 mg Caplet Pouch Carton
  • INGREDIENTS AND APPEARANCE
    NODOZ ALERTNESS AID  MAXIMUM STRENGTH
    caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9799
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVAL (Caplet) Size15mm
    FlavorImprint Code NoDoz
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9799-42 in 1 CARTON12/07/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:66715-9799-33 in 1 CARTON12/07/2017
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:66715-9799-61 in 1 CARTON12/07/2017
    360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:66715-9799-22 in 1 CARTON06/01/201812/30/2023
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:66715-9799-010 in 1 VIAL, PLASTIC; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34012/07/2017
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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