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Caffeine (AAA Pharmaceutical, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 5 BLISTER PACK in 1 CARTON (57344-020-02) > 8 TABLET in 1 BLISTER PACK Label Information
TABLET 2 BLISTER PACK in 1 CARTON (57344-020-01) > 8 TABLET in 1 BLISTER PACK Label Information
TABLET 10 BLISTER PACK in 1 CARTON (57344-020-03) > 8 TABLET in 1 BLISTER PACK Label Information

Complete Caffeine Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each tablet)

    Caffeine 200 mg


  • Purpose

    Alertness aid


  • Use

    helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness


  • 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.


  • Directions

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

  • Other information

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

  • Inactive ingredients

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


  • SPL UNCLASSIFIED SECTION

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


  • 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

  • INGREDIENTS AND APPEARANCE
    CAFFEINE 
    caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-020
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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)