Label: ADULT ALLERGY RELIEF DYE FREE- 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 February 24, 2020

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

  • Drug Facts

    Active ingredient [in each 10 mL]

    Diphenhydramine HCl, USP 25 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
    alcohol, 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

    measure only with dosing cup provided
    Keep dosing cup with product
    mL = milliliter
    do not take more than 6 doses in 24 hours

     Age (yr)

    Dose (mL)

    Adult and children 12 years and older

    10 mL to 20 mL (2 to 4 tsp) every 4 to 6 hrs

    Children under 12 years

    Do not use

  • Other information

    each 10 mL contains: sodium 30 mg
    store at room temperature. Store in outer carton until contents used
    do not refrigerate
    see bottom panel for lot number and expiration date
    protect from light
    ask a doctor before use if you have a sodium restricted diet.
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose

    Questions or Comments?

    1-866-467-2748

  • Package Label-Principal Display Panel 4 Fl Oz (118 Ml Bottle)

    NDC 0363-7100-04

    Dye-Free

    AdultAllergyRelief

    Diphenhydramine HCl | Antihistamine

    For Relief of:

    Runny nose
    Itchy, watery eyes
    Sneezing and Itchy Watery Eyes

    Sugar Free
    Cherry Flavor

    Naturally and Artificially Flavored

    4 FL OZ (118 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.



    Dye-Free Adult's Allergy Relief Diphenydramine HCl





  • INGREDIENTS AND APPEARANCE
    ADULT ALLERGY RELIEF  DYE FREE
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CHERRY (UNII: BUC5I9595W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorYELLOW (Colorless to Pale Yellow) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7100-041 in 1 CARTON01/30/2020
    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 finalpart34101/30/2020
    Labeler - WALGREEN COMPANY (008965063)