BENADRYL - diphenhydramine hydrochloride tablet, film coated 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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.

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Benadryl®

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

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

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

PRINCIPAL DISPLAY PANEL
BENADRYL  
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-226
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
Carnauba Wax (UNII: R12CBM0EIZ)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
D&C Red no. 27 (UNII: 2LRS185U6K)  
Aluminum Oxide (UNII: LMI26O6933)  
Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code B;WL;25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-226-501 in 1 CARTON06/04/2012
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50580-226-512 in 1 CARTON06/04/2012
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50580-226-532 in 1 POUCH; Type 0: Not a Combination Product06/04/2012
4NDC:50580-226-5460 in 1 CARTON07/27/2015
42 in 1 POUCH; Type 0: Not a Combination Product
5NDC:50580-226-624 in 1 CARTON01/02/2017
52 in 1 POUCH; Type 0: Not a Combination Product
6NDC:50580-226-524 in 1 CARTON06/04/2012
612 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:50580-226-563 in 1 PACKAGE02/01/2013
7NDC:50580-226-524 in 1 CARTON
712 in 1 BLISTER PACK; Type 0: Not a Combination Product
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)

Revised: 12/2019
Document Id: a4e944b6-a1fe-4701-bf6b-052f9b0d506f
Set id: 702f9786-7ce9-43e4-921d-e1db09612127
Version: 13
Effective Time: 20191206
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division