Label: CAFFEINE- caffeine tablet

  • NDC Code(s): 57344-020-01, 57344-020-02, 57344-020-03
  • Packager: AAA Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    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

    Do not use in children under 12 years of age

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

    For occasional use only. Not intended as a substitute for sleep.

    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 1 tablet not more often than every 3 to 4 hours
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  • Other information

    • each tablet contains: calcium 80 mg
    • store at room temperature 15°-30°C (59°-86°F)
    • retain carton for complete product information
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  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, dibasic calcium phosphate, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, pregelatinized starch

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

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  • PRINCIPAL DISPLAY PANEL - 16 Tablet Carton

    RESTORE u

    NDC 57344-020-01

    COMPARE TO THE ACTIVE
    INGREDIENT IN VIVARIN®

    Stay Awake

    ALERTNESS AID
    Caffeine

    16 TABLETS - 200 mg each

    Principal Display Panel - 16 Tablet Carton
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  • INGREDIENTS AND APPEARANCE
    CAFFEINE 
    caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57344-020
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAFFEINE (CAFFEINE) CAFFEINE 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C YELLOW NO. 6  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    STARCH, CORN  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code LL64;57344
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-020-01 2 in 1 CARTON
    1 8 in 1 BLISTER PACK
    2 NDC:57344-020-02 5 in 1 CARTON
    2 8 in 1 BLISTER PACK
    3 NDC:57344-020-03 10 in 1 CARTON
    3 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part340 12/15/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 181192162 MANUFACTURE(57344-020)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 010411533 PACK(57344-020)
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