Label: DIPHENHYDRAMINE HCL capsule, liquid filled

  • 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 16, 2014

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

  • Active Ingredient

    (in each capsule)

    Diphenhydramine HCl 25mg

  • Purpose

    Sleep Aid

  • Uses

    • For the relief of occasional sleeplessness
    • Reduces time to fall asleep if have difficulty falling asleep
  • Warnings

    Do not use

    • If children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
    • with other drug that cause drowsiness such as antihistamines and nighttime cold/flu products
    • Do not use with generic NyQuil®

    Ask a doctor before use if you have:

    • A breathing problem such as asthma, emphysema, or Chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • heart disease
    • You are taking a diuretic

      Ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid, when using this product :

    • Avoid alcoholic beverages and other drugs that cause drowsiness
    • Drowsiness will occur
    • Be careful when driving a motor vehicle or operating machinery

      Stop use and ask a doctor if sleeplessness persists continuously for more than two 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.

    Overdose Warning: Taking more than directed can cause serious health problems, In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Take only one dose per day (24 hours)- see Overdose warning.

    Adults and Children 12 years and over

    • One Dose = Two 25 mg LiquiCaps (50 mg) at bedtime if needed or as directed by a doctor
  • Other Information

    • Store at 20-25°C (68-77°F)
    • Avoid excessive heat above 40°C(104°F) and high humidity
    • Protect from light
  • Inactive Ingredients

    FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol, Titanium Dioxide

  • Questions?

    Call 1-855-314-1850

    TAMPER EVIDENT: This Package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors. 

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    108b7ac2-figure-01

    NDC: 58805-001-14 LIQUID GELS

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58805-001
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code 602
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58805-001-143600 in 1 BLISTER PACK
    11 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2013
    Labeler - Agile Pharmachem (650687853)
    Registrant - Agile Pharmachem (650687853)