Label: ALLERGY DYEFREE capsule, liquid filled

  • 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 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 finalpart33609/15/2013
    Labeler - Allegiant Health (079501930)
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