Label: ALLERGY RELIEF ANTIHISTAMINE- 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 May 6, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Diphenhydramine HCl 25mg

  • 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

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

    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

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • 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 softgel
    children 6 to under 12 years1 softgel
    children under 6 years of agedo not use this product
  • Other information

    • store at room temperature between 20-25°C (68-77°F)
    • avoid excessive heat, humidity and light
  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions or Comments?

    Call: 1-888-577-8033 Monday - Friday 9am-4:30pm EST

  • SPL UNCLASSIFIED SECTION

    Distributed by C.D.M.A., Inc.©
    43157 W 9 Mile Rd
    Novi, MI 48375

  • PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton

    QC®
    QUALITY
    CHOICE

    NDC 63868-474-24

    *Compare to the active
    Ingredient in BENADRYL®
    Allergy LIQUI-GELS®

    Dye-Free

    Allergy Relief

    Antihistamine

    • Relieves sneezing
    • Itchy, watery eyes
    • Runny nose
    • Itchy throat

    Diphenhydramine HCl
    25 mg

    24 Softgels

    Actual Size

    PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF ANTIHISTAMINE 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-474
    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)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    propylene glycol (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    sorbitan (UNII: 6O92ICV9RU)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (clear) Scoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code 783
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-474-242 in 1 CARTON05/01/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/01/2021
    Labeler - CDMA Inc (011920774)