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

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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 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
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
74 in 1 CARTON
712 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:50580-226-202 in 1 CARTON01/15/2024
81 in 1 CARTON
8100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/01/2008
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 1/2024
Document Id: 10168032-5bd0-0edb-e063-6394a90a348f
Set id: 702f9786-7ce9-43e4-921d-e1db09612127
Version: 23
Effective Time: 20240129
 
Johnson & Johnson Consumer Inc.