Label: ALLERGY RELIEF- diphenhydramine hcl liquid

  • 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 November 11, 2020

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

  • Active ingredient (in each 20 mL)

    Diphenhydramine HCl 50 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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

    • do not exceed recommended dosage
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages
    • excitability may occur, especially in children

    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

    • do not take more than 6 doses in 24 hours
    • mL = milliliter; FL OZ = fluid ounce
    • only use the dose cup provided
    • adults and children 12 years and over: take 10 mL to 20 mL every 4 to 6 hours, or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • each 20 mL contains: sodium 15 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    CVS
    Health®

    Dye Free

    MAXIMUM
    STRENGTH

    Allergy
    Relief

    LIQUID MEDICATION

    DIPHENHYDRAMINE HCI
    50 mg/20 mL
    ORAL SOLUTION
    Antihistamine

    Relieves:

    • Sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itchy throat

    Cherry Flavor

    Alcohol free
    Actual Bottle Size
    on Side Panel

    4 FL OZ (118 mL)

    DYE
    FREE

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
    SEAL UNDER CAP IS BROKEN OR MISSING

    50844 ORG102007236

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2020 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    V-18615

    CVS 44-072

    CVS 44-072

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-798
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-798-361 in 1 CARTON10/27/2020
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/27/2020
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305MANUFACTURE(69842-798) , PACK(69842-798)