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 over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do 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 Type HUMAN OTC DRUG Item Code (Source) NDC:50580-226
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
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
Color PINK Score no score
Shape OVAL Size 11mm
Flavor Imprint Code B;WL;25
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50580-226-50 1 in 1 CARTON 06/04/2012
1 100 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:50580-226-51 2 in 1 CARTON 06/04/2012
2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3 NDC:50580-226-53 2 in 1 POUCH; Type 0: Not a Combination Product 06/04/2012
4 NDC:50580-226-54 60 in 1 CARTON 07/27/2015
4 2 in 1 POUCH; Type 0: Not a Combination Product
5 NDC:50580-226-62 4 in 1 CARTON 01/02/2017
5 2 in 1 POUCH; Type 0: Not a Combination Product
6 NDC:50580-226-52 4 in 1 CARTON 06/04/2012
6 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
7 NDC:50580-226-56 3 in 1 PACKAGE 02/01/2013
7 NDC:50580-226-52 4 in 1 CARTON
7 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/01/2008
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 6/2018
Document Id: 14e51701-3d13-4103-bae7-a355fdb2f956
Set id: 702f9786-7ce9-43e4-921d-e1db09612127
Version: 12
Effective Time: 20180620
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division