AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]

AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]
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NDC 21130-944-11
Set ID ce4da457-805f-4d2a-8667-6516eea85221
Category HUMAN OTC DRUG LABEL
Packager Better Living Brands, LLC
Generic Name
Product Class
Product Number
Application Number PART340
  • Active ingredient (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 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 heart beat.

    Do not use

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

    Stop use and ask a doctor if

     fatigue or drowsiness persists or continues to recur.

    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 and over: take 1/2 to 1 caplet not more often than every 3 to 4 hours 
    • children under 12 years: do not use
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, dextrates hydrated, dibasic calcium phosphate dihydrate, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Signature
    care®
    Quality Guaranteed

    Compare to Maximum Strength NoDoz® active ingredient*

    NDC 21130-944-11

    Maximum Strength
    Awake
    CAFFEINE 200 mg
    Alertness Aid

    • Equal to About a Cup of Coffee

    Actual Size

    60 CAPLETS

    *This product is not manufactured or distributed by Lil' Drug Store Products, Inc., distributors of Maximum Strength NoDoz®.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    50844   REV1219A34411

    DISTRIBUTED BY
    BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929
    www.betterlivingbrandsLLC.com

    OUR PROMISE
    QUALITY & SATISFACTION
    100 % GUARANTEED
    OR YOUR MONEY BACK.

    Signature Care 44-344

    Signature Care 44-344

  • INGREDIENTS AND APPEARANCE
    AWAKE  MAXIMUM STRENGTH
    caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-944
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize15mm
    FlavorImprint Code 44;344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-944-111 in 1 CARTON04/14/1998
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34004/14/1998
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(21130-944)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(21130-944)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(21130-944)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(21130-944)

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