BENADRYL- diphenhydramine hydrochloride tablet, film coated 
Lil' Drug Store Products, Inc.

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, crospovidone, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

call 1-877-717-2824 or www.benadryl.com

Repackaged and distributed by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton

Benadryl®

ALLERGY

Diphenhydramine HCl | antihistamine

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat

2
ULTRATAB™*
TABLETS

25 mg EACH *small tablet size

Lil'
Drug Store®

Principal Display Panel - 2 Tablet Pouch Carton
BENADRYL 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9706(NDC:50580-226)
Route of Administration ORAL DEA Schedule     
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)  
crospovidone (UNII: 68401960MK)  
D&C red no. 27 (UNII: 2LRS185U6K)  
aluminum oxide (UNII: LMI26O6933)  
calcium phosphate, dibasic, dihydrate (UNII: O7TSZ97GEP)  
hypromelloses (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
cellulose, microcrystalline (UNII: OP1R32D61U)  
polyethylene glycols (UNII: 3WJQ0SDW1A)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
stearic acid (UNII: 4ELV7Z65AP)  
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:66715-9706-1 1 in 1 CARTON
1 2 in 1 POUCH
2 NDC:66715-9706-2 2 in 1 CARTON
2 2 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 09/16/2010
Labeler - Lil' Drug Store Products, Inc. (093103646)

Revised: 12/2012
Document Id: fc926f1b-800d-4a65-a2a8-a8a736ee5173
Set id: de2a64ce-c169-4162-b79e-d3809bea2147
Version: 2
Effective Time: 20121226
 
Lil' Drug Store Products, Inc.