Label: DORMMY-LON- diphenhydramine hydrochloride tablet

  • NDC Code(s): 83164-000-01
  • Packager: Haendel Farma, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

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 January 23, 2023

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  • Drug Facts

  • Active Ingredient (in each pill)

    Diphenhydramine hydrochloride 25 mg

    Purpose

    Nighttime sleep-aid

  • Uses:

    • Helps to reduce difficulty in falling sleep
    • For the relief of occasional sleeplessness
  • Warnings

    Ask a doctor before use if you have:

    • A breathing problem such as emphysema or chronic bronchitis
    • Glaucoma
    • Difficulty in urination due to an enlarged prostate gland

    Do not use

    • For children under 12 years of age
    • With any other product containing diphehydramine

    Ask a doctor or pharmacist before use it if you are

    taking sedatives, tranquilizers or any other drugs

    When using this product

    • Avoid alcoholic beverages

    Stop use and ask a doctor if 

    sleeplessness persists continuosly for more than 2 weeks, In sommia 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

    • Take only one dose per day (24 hours)
     Adults and children 12 years & over 2 pills or as directed by a doctor
     children under 12 years Do not use 

  • Inactive ingredients

    Lactose, P.V.P., Starch, Blue Color FD&C # 1, Microcrystalline Cellulose, Croscarmellose, Sodium, Magnesium Stearate

  • Other information

    • Store at 68° - 77 °F (20-25 °C)
    • Protect from light.
    • See printed for lot number and exp. date.
  • Package Labeling:

    Outer Package0Inner Package0

  • INGREDIENTS AND APPEARANCE
    DORMMY-LON 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83164-000
    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
    SODIUM (UNII: 9NEZ333N27)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE (UNII: 029TFK992N)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeOVALSize12mm
    FlavorImprint Code Q
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83164-000-011 in 1 BOX01/04/2023
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01001/04/2023
    Labeler - Haendel Farma, S.A. de C.V. (816368628)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haendel Farma, S.A. de C.V.816368628manufacture(83164-000)
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