Label: 357 SUPER MAGNUM- caffeine 200mg tablet, multilayer

  • 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 May 19, 2016

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  • 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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