357 SUPER MAGNUM (CAFFEINE 200MG) TABLET, MULTILAYER [KING RICHARD PROMOTIONS DBA DBI ]

357 SUPER MAGNUM (CAFFEINE 200MG) TABLET, MULTILAYER [KING RICHARD PROMOTIONS DBA DBI ]
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NDC 70682-941-03, 70682-941-21, 70682-941-36, 70682-941-51
Set ID 1acbee4e-6f23-4d0e-ab08-696c7d4cbd22
Category HUMAN OTC DRUG LABEL
Packager King Richard Promotions dba DBI
Generic Name
Product Class
Product Number
Application Number PART340
  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Caffeine 200mg

  • PURPOSE

    Purpose: Alertness Aid

  • INDICATIONS & USAGE

    Use: Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.

  • WARNINGS

    Warnings: 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.

    For occasional use only.Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a doctor.

    Do not give to children under 12 years of age.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age or older: 1/2 to 1 tablet, not more often than every 3-4 hours.

    Children under 12 years: do not use.

  • OTHER SAFETY INFORMATION

    Other Information:

    Each tablet contains: Calcium 48mg

    Store at room temperature.

    Avoid excess heat (greater than 100°F) or humidity.

  • INACTIVE INGREDIENT

    Inactive ingredients: blue #1 lake, croscarmellose sodium*, dicalcium phosphate , magnesium silicate*, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, red #27 lake,  silicon dioxide, stearic acid, sugar, and titanium dioxide*

    *Contains one or more of these ingredients

  • QUESTIONS

    Questions?

    Call toll-free 1-800-428-2352 Monday through Friday, 8a.m. to 5p.m. EST.

  • PRINCIPAL DISPLAY PANEL

    357magnum500

  • PRINCIPAL DISPLAY PANEL

    357magnum100

  • PRINCIPAL DISPLAY PANEL

    357magnum36

  • PRINCIPAL DISPLAY PANEL

    357magnum3

  • INGREDIENTS AND APPEARANCE
    357 SUPER MAGNUM 
    caffeine 200mg tablet, multilayer
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70682-941
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containCROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    May containMAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (with blue specks;pink) Scoreno score
    ShapecapsuleSize15mm
    FlavorImprint Code 357HR;Magnum
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70682-941-033 in 1 PACKET; Type 0: Not a Combination Product05/19/2016
    2NDC:70682-941-3636 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2016
    3NDC:70682-941-21100 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2016
    4NDC:70682-941-51500 in 1 PACKAGE; Type 0: Not a Combination Product05/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34005/19/2016
    Labeler - King Richard Promotions dba DBI (949538644)
    Registrant - King Richard Promotions dba DBI (949538644)

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