JET-ASLEEP DOUBLE STRENGTH NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BELL PHARMACEUTICALS, INC.]

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  • JET-ASLEEP DOUBLE STRENGTH NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BELL PHARMACEUTICALS, INC.]

JET-ASLEEP DOUBLE STRENGTH NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BELL PHARMACEUTICALS, INC.]
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NDC 15579-828-17, 15579-828-23
Set ID d053201d-9ae2-47c2-8f07-3e4b4af940b6
Category HUMAN OTC DRUG LABEL
Packager Bell Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART338
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  • Drug Facts

  • Active ingredient (in each caplet)

    Diphenhydramine HCL 50mg

    Purpose

    Nighttime sleep-aid

  • Uses

    • for relief of occasional sleeplessness
  • Warnings

    Do not use

    • in children under 12 years of age 
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor  before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • traouble urinating due to a to enlarged prostate gland
    • glaucome 

    Ask a doctor or pharmacist before useif you are 

    • taking Sedatives or tranquilizers

    When using this product

    avoid alcoholic drinks

    Stop use and ask a doctor

    if sleeplessness lasts continuosly for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

    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 caplets at bedtime if needed, or as directed by a doctor
     children under 12 years do not ues

  • Other information

    • each caplet contains:calcium 35 mg
    • store between 15°-30°C (59°-86°F)
    • don not use if tamper-evident seal is broken or missing
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD & C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, stearic acid

  • Questions or comments?

    1-800-328-5890 Weekdays 8:30-5:00 CST

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    JET-ASLEEP DOUBLE STRENGTH NIGHT TIME SLEEP AID 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15579-828
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code 350
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15579-828-233 in 1 BOX10/07/2017
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:15579-828-171 in 1 BOX10/07/2017
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33810/07/2017
    Labeler - Bell Pharmaceuticals, Inc. (140653770)
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