Label: ADULT ALLERGY RELIEF- diphenhydramine hydrochloride solution

  • 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 27, 2020

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

  • Drug Facts

    Active ingredient [in each 20 mL]

    Diphenhydramine HCl, USP 50 mg

  • Purpose

    Antihistamine

  • Uses

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

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin
  • Ask a doctor before use if you have

    • a breathing problem such as chronic bronchitis
    • glaucoma
    • a sodium-restricted diet
    • trouble urinating due to enlarged prostate

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

  • When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • 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 (1-800-222-1222) right away.

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    • not to exceed 300 mg in 24 hours
    • mL = milliliter
     Age (yr)
    Dose (mL)
    Adult and children 12 years and older
    10 mL to 20 mL
    Children under 12 years
    Consult a doctor

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.


  • Other information

    • each 20 mL contains: sodium 56 mg
    • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, flavor, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

    Questions or Comments?

    1-888-287-1915

    DISTRIBUTED BY: Wal Mart Stores, Inc.,
    Bentonville, AR 72716
    PRODUCT OF INDIA

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

    NDC 49035-986-24

    equate™

    Quality
    Guaranteed

    Maximum Strength/Dye Free
    Adult
    Allergy
    Relief
    Liquid Medication

    Diphenhydramine Hydrochloride
    50 mg/20 mL
    Oral Solution
    Antihistamine

    Relief of:

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

    Alcohol Free
    Cherry Flavor

    4 FL OZ (118 mL)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)




  • INGREDIENTS AND APPEARANCE
    ADULT ALLERGY RELIEF 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-986
    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)  
    CHERRY (UNII: BUC5I9595W)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorYELLOW (Colorless to Pale Yellow) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-986-241 in 1 CARTON05/03/201708/01/2022
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/03/201708/01/2022
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(49035-986)