Label: DIPHENHYDRAMINE HCL liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 20, 2025

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  • Drug Facts

    Active ingredient (in each 30 mL dose cup) 

    Diphenhydramine HCl 50mg

  • Purpose

    Nightime sleep-aid

  • Uses

    • for the relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep

  • Warnings

    Do not use

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

  • Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the 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 continuosly for more than 2 weeks. Insomnia may be a symptom of serious underlying medical ilness.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • take only one dose (30 mL) per day (24 hours)
    • only use dose cup provided

    AgeDose
    adults and children 12 years and over30 mL at bedtime if needed or as directed by a doctor
    children under 12 yearsdo not use

  • Other information

    • each 30 mL dose cup contains:sodium 24 mg
    • store between 15-30°C (59-86°F).

  • Inactive ingredients

    anhydrous citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.

  • Questions or comments?

    1-844-912-4012

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37835-519
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HCL (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HCL50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37835-519-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01005/01/2025
    Labeler - BI-MART (027630078)
    Registrant - BI-MART (027630078)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rnv LLC118917568manufacture(37835-519)
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