Label: BENADRYL- 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 August 29, 2017

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 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. 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 between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.
    • do not use if carton is open or blister unit is broken
  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol, purified water, sorbitol. Capsules are imprinted with edible dye-free ink.

  • Questions or comments?

    call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label

    Austin/Travis Co. Health & Human Services Dept.

    Benadryl
    25mg/24
    Caps

    Date:

    Name:
    Dr.

    USE AS DIRECTED.

    1/1/01

    123456

    Benadryl 25mg/24 CAPS NDC 76413-332-24

    Batch: 123456
    Lot: 123456
    Exp: 1/1/01
    Mckneil

    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label
  • INGREDIENTS AND APPEARANCE
    BENADRYL 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-332(NDC:50580-228)
    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)  
    sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITE (Clear) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code BENADRYL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76413-332-242 in 1 CARTON03/01/2009
    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 FINALpart34103/01/2009
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Texas Community Health Centers079674019REPACK(76413-332) , RELABEL(76413-332)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!