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

  • NDC Code(s): 0067-2070-60
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 August 10, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient (in each caplet)

    Caffeine 200 mg

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  • Purpose

    Alertness Aid

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  • Use

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

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  • 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

    in 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.

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  • Directions

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

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

    benzoic acid, carnauba wax, corn starch, FD&C blue #1, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, sucrose, titanium dioxide

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  • Questions or comments?

    1-800-468-7746

    www.nodoz.com

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  • Principal Display Panel

    NDC 0067-2070-60

    NoDoz®

    Max Strength ● Fast Acting

    Alertness Aid

    60 CAPLETS

    200 mg CAFFEINE EACH

    TAMPER-EVIDENT BOTTLE

    DO NOT USE IF INNER FOIL SEAL PIRNTED WITH “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSING

    Distributed by: GSK Consumer Healthcare

    Warren, NJ 07059

    ©2016 GSK or its licensor. All rights reserved.

    12762

    NoDoz 200 mg 60 count carton
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  • INGREDIENTS AND APPEARANCE
    NODOZ  MAXIMUM STRENGTH ALERTNESS AID
    caffeine tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2070
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE (Off-White) Score 2 pieces
    Shape OVAL (Caplet) Size 15mm
    Flavor Imprint Code NoDoz
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-2070-60 1 in 1 CARTON 12/31/2009 07/11/2019
    1 60 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part340 12/31/2009 07/11/2019
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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