BENADRYL- diphenhydramine hydrochloride tablet, film coated 
Select Corporation

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

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)

Repackaged and Distributed by:
Select Corporation
Carrollton, TX 75007

Distributed by: JOHNSON & JOHNSON CONSUMER INC
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Single-Pack

Benadryl®
ALLERGY

2 Tablets
Single-Pack

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Single-Pack
BENADRYL 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-960(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:52904-960-041 in 1 BLISTER PACK09/01/2008
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:52904-960-052 in 1 BLISTER PACK09/01/2008
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:52904-960-2020 in 1 CARTON09/01/2008
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:52904-960-2525 in 1 CARTON09/01/2008
42 in 1 POUCH; Type 0: Not a Combination Product
5NDC:52904-960-3030 in 1 CARTON09/01/2008
52 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/2008
Labeler - Select Corporation (053805599)

Revised: 3/2022
Document Id: 5e630d0e-4bc2-4f90-ac6a-e5e297d94cb8
Set id: d3f44425-db82-4569-8ed0-2fe990b23384
Version: 1
Effective Time: 20220330
 
Select Corporation