Label: DORMIN- diphenhydramine hydrochloride capsule

  • NDC Code(s): 52412-100-02, 52412-100-32, 52412-100-72
  • Packager: Randob Labs,Ltd.
  • 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 April 12, 2019

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

View All Sections
  • Active ingredient

    Diphenhydramine Hydrochloride

  • Purpose

  • Keep Out of Reach of Children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    ▪
    helps to 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 Doctor

    As a doctor before use if you have

    ▪
    a breathing problem such as emphysema or chronic bronchitis
    ▪
    glaucoma
    ▪
    trouble urinating due to enlarged prostate gland

    Ask Doctor/Pharmacist

    As a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When Using

    When using this product

    ▪
    avoid alcoholic drinks

    Stop Use

    Stop use and ask a doctor if sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

    Pregnancy or Breast Feeding

    If pregnant or breast-feeding, ask a health professional before use.

  • Directions

    Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctor

    Children under 12 years of age: Do not give this product to children under 12 years of age

  • Other Information

    ▪
    keep in dry place

    Use by expiration date on pack

  • Inactive Ingredients

    FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene Glycol, Silicon Dioxide, Talc.

  • Principal Display Panel

    Dormin®

    THE NIGHTTIME SLEEP-AID

    With Diphenhydramine Hydrochloride

    •
    FAST
    •
    SAFE
    •
    EFFECTIVE

    72 Capsules

    R:\eDRLS\Drug Listing Images\Dormin\container-label.jpg
  • INGREDIENTS AND APPEARANCE
    DORMIN 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-100
    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 RED NO. 3 (UNII: PN2ZH5LOQY)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINK (pink cap/pink body with red band) Scoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code Dormin;25mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-100-7272 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1992
    2NDC:52412-100-3232 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1992
    3NDC:52412-100-022 in 1 POUCH; Type 0: Not a Combination Product03/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33801/01/1992
    Labeler - Randob Labs,Ltd. (061995007)
    Registrant - Randob Labs, Ltd. (061995007)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!