Label: REVASOL SLEEP AID- diphenhydramine hcl liquid

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

Drug Label Information

Updated March 11, 2025

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

  • ACTIVE INGREDIENT

    Active ingredient (in each 30 mL dose cup) Purpose
    Diphenhydramine HCl 50mg.................................................... Nightime sleep-aid

  • PURPOSE

    Nightime sleep-aid

  • INDICATIONS & USAGE

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

  • WARNINGS

    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 DOCTOR

    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 DOCTOR/PHARMACIST

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

  • WHEN USING

    When using this product
    • avoid alcoholic beverages

  • STOP USE

    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.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

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

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

  • OTHER SAFETY INFORMATION

    Other information
    each 30 mL dose cup contains: sodium 4 mg
    • store between 15-30°C (59-86°F).
    TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or
    missing.

  • INACTIVE INGREDIENT

    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

    Questions or comments 1-888-446-4753
    Monday - Friday (9 AM - 5 PM EST)

  • PRINCIPAL DISPLAY PANEL

    REVASOL SLEEP.jpg

  • INGREDIENTS AND APPEARANCE
    REVASOL SLEEP AID 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84379-284
    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
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84379-284-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/03/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01002/03/2025
    Labeler - Rnv LLC (118917568)
    Registrant - Rnv LLC (118917568)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rnv LLC118917568manufacture(84379-284)