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

Dosage form: kit
Ingredients: diphenhydramine hydrochloride 25mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-370

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 carton tape and foil inner seal imprinted with "SAFETY SEAL®" are broken or missing

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

100+48 = 148

ULTRATABS®*
TABLETS

Benadryl®

WORKS WHEN YOU
NEED IT MOST™

*small tablet size

BENADRYL 
diphenhydramine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-370
Packaging
#Item CodePackage Description
1NDC:50580-370-011 KIT in 1 PACKAGE
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 100 
Part 24 BLISTER PACK 48 
Part 1 of 2
BENADRYL 
diphenhydramine hydrochloride tablet, film coated
Product Information
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 lake 
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
11 BOTTLE in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/04/2012
Part 2 of 2
BENADRYL 
diphenhydramine hydrochloride tablet, film coated
Product Information
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 lake 
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
14 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/04/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/12/2017
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

← See all Benadryl brands

Medically reviewed on Jun 22, 2017

Further information

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

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