Label: ALLERGY DYEFREE capsule, liquid filled

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

Drug Label Information

Updated April 26, 2021

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  • Active ingredient(s)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Use(s)

    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

    temporarily relieves these symptoms due to the common cold: 

    • runny nose
    • sneezing
  • 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

    • a breathing problem such as emphysema or chronic bronchitis 
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if

    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

    Pregnancy/Breastfeeding

    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
    • do not take more than 6 doses in 24 hours

    Adults and children 12 years and over: 1 to 2 softgels

    Children 6 to under 12 years: 1 softgel

    Children under 6 years: do not use this product in children under 6 years of age

  • Other information

    • do not use if blister is torn or broken
  • Storage

    • store between 20-25 °C (68-77 °F).
    • Avoid high humidity and excessive heat. Protect from light. 
  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

  • Questions

    Call 1-888-952-0050
    Monday through Friday 9AM - 5PM EST

  • Principal Display Panel

    Diphenhydramine HCL 25mg

    Diphenhydramine HCL 25mg


  • INGREDIENTS AND APPEARANCE
    ALLERGY DYEFREE 
    allergy dyefree capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-409
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    Coloryellow (Clear) Scoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code PC4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-409-8612 in 1 BLISTER PACK; Type 0: Not a Combination Product04/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00909/15/2013
    Labeler - Allegiant Health (079501930)
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