Label: CAFFEINE tablet

  • 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 September 15, 2022

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  • Drug Facts

    Active ingredient (in each tablet)
    Caffeine 200 mg

  • PURPOSE

    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 (1-800-222-1222) right away.

  • Directions

    ■ adults and children 12 years of age and over: take 1/2 to 1 tablet not more often than every 3 to 4 hours

  • Other information

    ■ each tablet contains: calcium 65 mg
    ■ Store in a dry place at 15° – 30°C (59° – 86°F)

  • INACTIVE INGREDIENT

    corn starch, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica

  • Questions or comments?


    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    Distributed by:
    NORTHEAST PHARMA
    South Burlington, VT 05403
    www.heartlandpharmaco.com
    1-800-383-0648

    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®.

  • PRINCIPAL DISPLAY PANEL

    NDC 80136-855-26

    Compare to active ingredient in Maximum Strength NoDoz ®*

    Heartland Pharma Co.

    Maximum Strength

    Caffeine Tablets

    Caffeine, 200 mg

    Alertness Aid

    60 Tablets

    Harland Pharma

  • INGREDIENTS AND APPEARANCE
    CAFFEINE 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-855
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 212;212
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80136-855-261 in 1 CARTON02/14/2022
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34001/20/2022
    Labeler - Northeast Pharma (081232935)
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