Label: ALLERGY- diphenhydramine hydrochloride 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 September 30, 2020

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  • Active ingredient (in each capsule)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    •
    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 you have

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

    Ask 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 right away (1-800-222-1222).

  • 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 capsules

    children 6 to under 12 years

    1 capsule

    children under 6 years

    do not use this product in children

    under 6 years of age
  • Other information

    •
    store at 20-25°C (68-77°F). Protect from heat, humidity and light.
    •
    do not use if blister unit is broken or torn
  • Inactive ingredients

    edible dye-free ink*, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

  • Questions or comments?

    1-800-632-6900

  • Package/Label Principal Display Panel

    COMPARE TO the active ingredient of BENADRYL® ALERGY LIQUI-GELS® See top panel

    OUR PHARMACIST RECOMMENDED

    Allergy Liquid Gels

    RELIEVES:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Throat

    Diphenhydramine HCl 25 mg EACH

    Antihistamine

    DYE-FREE

    actual size

    24 LIQUID GELS**

    25 mg EACH

    **liquid-filled capsules

    2s3-45-allergy-liquid-gels
  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-847
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOW (Clear) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 2S3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-847-0124 in 1 CARTON07/16/2019
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/16/2019
    Labeler - Kroger Company (006999528)
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