Label: SOHMED ALERTNESS AID- 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 August 20, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each caplet)

    Caffeine 200 mg

  • 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 cofffee.
    • 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 heart beat.

    Do not use

    • in children under 12 years of age
    • as substitute for sleep

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

    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 ½ to 1 caplet not more often than every 3 to 4 hours.
  • Other information

    • Store at controlled room temperature 15°-30°C (59°-86°F)
    • See end flap for expiration date and lot number
  • Inactive ingredients

    benzoic acid, corn starch, FD&C blue # 1, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, sucrose, titanium dioxide, carnauba wax.

  • Question or comments?

    1(856) 2863646

  • SPL UNCLASSIFIED SECTION

    Distributed by : Sohm, Inc.
    6920 Knott Ave., Suit A-C,
    Buena Park, CA 90621

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

    SohMed™

    NDC XXXXXXXXXX

    *Compare to the Active Ingredients in Vivarin®

    ALERTNESS AID
    Caffeine
    Caffeine 200 mg

    Restore mental alertness or wakefulness

    24 Caplets

    Principal Display Panel - 24 Caplet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SOHMED ALERTNESS AID 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50405-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine200 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVALSize11mm
    FlavorImprint Code CRX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50405-005-241 in 1 CARTON
    124 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34008/25/2013
    Labeler - SOHM Inc. (009303848)
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