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 8, 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

    FD&C blue no. 2, hydroxypropyl cellulose, hypromellose 2910, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, silicic acid anhydride, sodium starch glycolate, stearic acid, titanium dioxide

  • Package label

    Vida Mia Sleep Aid Original Formulaimage of Sleep-aid carton

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-079
    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)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code BD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59970-079-162 in 1 BOX
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33802/01/2013
    Labeler - Navarro Discount Pharmacies,LLC (094930963)
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