Label: ALLERGY RELIEF- diphenhydramine hcl capsule

  • 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 January 18, 2012

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

  • Active ingredient

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose

    • itchy, watery eyes

    • sneezing 

    • 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 you have

    • 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 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 of 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

    • take every 4 to 6 hours

    • do not take more than 6 doses in 24 hours
      adults and children 12 years of age and over1 to 2 capsules 
      children 6 to under 12 years of age1 capsule 
      children under 6 years of agedo not use this product in children under 6 years of age 
  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)

    • protect from moisture

    • see end flap for expiration date and lot number

  • Inactive ingredients

    butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, propylparaben, polysorbate 80, silica gel

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL®*

    Welby®

    HEALTH

    Blocks Histamine

    allergy relief

    Diphenhydramine Hydrochloride • Antihistamine

    Relieves Sneezing, Itchy, Watery Eyes, Runny Nose & Itchy Throat due to Allergies & Colds

    EACH CAPSULE INDIVIDUALLY BANDED FOR YOUR PROTECTION

    TAMPER EVIDENT: PRODUCT SEALED IN PLASTIC STRIPS, CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

    50844    REV0810H19008

    Distributed by ALDI, Inc.

    Batavia, IL 60510-1477

    welby 190

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64024-190
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 44;190
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64024-190-081 in 1 CARTON
    124 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33603/15/1990
    Labeler - ALDI INC. (944259522)