Label: SLEEP AID- diphenhydramine hydrochloride tablet 

  • NDC Code(s): 59970-079-16
  • Packager: Navarro Discount Pharmacies,LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Diphenhydramine HCL 25mg

    Close
  • Purpose

    Nighttime sleep-aid

    Close
  • Use

    helps reduce difficulty falling asleep

    Close
  • 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.

    Close
  • Directions

    • adults and children 12 years and older:
    take 2 tablets at bedtime if needed or as directed by your doctor.
    Close
  • Other information

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

    Close
  • Package label

    Vida Mia Sleep Aid Original Formulaimage of Sleep-aid carton

    Close
  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59970-079
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    HYDROXYPROPYL CELLULOSE  
    MICROCRYSTALLINE WAX  
    ANHYDROUS LACTOSE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    SILICON DIOXIDE  
    HYPROMELLOSE 2910 (50 MPA.S)  
    POLYETHYLENE GLYCOL 6000  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code BD
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59970-079-16 2 in 1 BOX
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part338 02/01/2013
    Labeler - Navarro Discount Pharmacies,LLC (094930963)
    Close