Label: SLEEP AID- diphenhydramine hcl 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 February 15, 2013

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  • Active ingredient (in each tablet)

    Diphenhydramine HCL 25mg

  • Purpose

    Nighttime sleep-aid

  • Use

    helps reduce difficulty falling asleep

  • 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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

  • When using this product

    avoid alcoholic beverages

  • Stop use and ask a doctor if

    sleeplessness persists continuously 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 accidental overdose get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years and older

    take 2 tablets at bedtime if needed or as directed by your doctor.

  • Other information

    • each tablet contains:calcium 0.2mg
    • store at room temperature
    • avoid excessive heat (greater than 100°F) or humidity
  • Inactive ingredients

    FDC blue #1, microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch, dicalcium phosphate, stearic acid, silcon dioxide, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol

  • Package label

    Enter section text hereimage of Sleep-aid carton

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHANETHIOL (UNII: M439R54A1D)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code RM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0160-22 in 1 BOX
    112 in 1 BLISTER PACK
    2NDC:67510-0160-02 in 1 BOX
    210 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33808/18/2011
    Labeler - Kareway Product, Inc. (121840057)
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