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Benadryl by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Medically reviewed on Jun 20, 2018

Dosage form: tablet, film coated
Ingredients: Diphenhydramine Hydrochloride 25mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-226

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.

Benadryl®

Drug Facts

Active ingredient (in each tablet)

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, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information
  • each tablet contains: calcium 15 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • do not use if carton is opened or if blister unit is broken

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-226-51

Benadryl®

ALLERGY

Diphenhydramine HCl 25mg | Antihistamine

✓ Sneezing
✓ Runny Nose
✓ Itchy, Watery Eyes
✓ Itchy Throat

ULTRATABS®*
*small tablet size

actual size

24 TABLETS

BENADRYL  
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-226
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax 
Croscarmellose Sodium 
D&C Red no. 27 
Aluminum Oxide 
Dibasic Calcium Phosphate Dihydrate 
Hypromellose, Unspecified 
Magnesium Stearate 
Microcrystalline Cellulose 
Polyethylene Glycol, Unspecified 
Polysorbate 80 
Titanium Dioxide 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint CodeB;WL;25
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-226-501 BOTTLE in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE
2NDC:50580-226-512 BLISTER PACK in 1 CARTON
212 TABLET, FILM COATED in 1 BLISTER PACK
3NDC:50580-226-532 TABLET, FILM COATED in 1 POUCH
4NDC:50580-226-5460 POUCH in 1 CARTON
42 TABLET, FILM COATED in 1 POUCH
5NDC:50580-226-624 POUCH in 1 CARTON
52 TABLET, FILM COATED in 1 POUCH
6NDC:50580-226-524 BLISTER PACK in 1 CARTON
612 TABLET, FILM COATED in 1 BLISTER PACK
7NDC:50580-226-563 CARTON in 1 PACKAGE
7NDC:50580-226-524 BLISTER PACK in 1 CARTON
712 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2008
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

See Also

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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