BENADRYL - diphenhydramine hydrochloride tablet, film coated 
McNeil Consumer Healthcare Div McNeil-PPC, 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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Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

Do not use 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

  • take every 4 to 6 hours
  • do not take more than 6 times in 24 hours
adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use this product in children under 6 years of age

Other information

  • each tablet contains: calcium 15 mg
  • store between 20 - 25°C (68 - 77°F). Avoid high humidity. Protect from light.
  • do not use if carton is opened or if blister unit is broken
  • see side panel for lot number and expiration date

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

PRINCIPAL DISPLAY PANEL

NEW
LOOK!
SAME RELIEF

NDC 50580-226-24

Benadryl®

ALLERGY

Diphenhydramine HCl | Antihistamine

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat

24
ULTRATAB™* TABLETS 25 MG EACH
*small tablet size

Principal Display Panel - 24 Tablets Carton
BENADRYL  
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-226
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine25 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax 
Crospovidone 
D&C Red no. 27 
Aluminum Oxide 
Calcium Phosphate, Dibasic, Dihydrate 
Hypromelloses 
Magnesium Stearate 
Cellulose, Microcrystalline 
Polyethylene Glycols 
Polysorbate 80 
Stearic Acid 
Titanium Dioxide 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code B;WL;25
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-226-0260 in 1 CARTON
12 in 1 POUCH
2NDC:50580-226-101 in 1 CARTON
2100 in 1 BOTTLE
3NDC:50580-226-141 in 1 CARTON
3148 in 1 BOTTLE
4NDC:50580-226-242 in 1 CARTON
412 in 1 BLISTER PACK
5NDC:50580-226-484 in 1 CARTON
512 in 1 BLISTER PACK
6NDC:50580-226-501 in 1 CARTON
6100 in 1 BOTTLE
7NDC:50580-226-512 in 1 CARTON
712 in 1 BLISTER PACK
8NDC:50580-226-524 in 1 CARTON
812 in 1 BLISTER PACK
9NDC:50580-226-532 in 1 POUCH
10NDC:50580-226-551 in 1 CARTON
10148 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2008
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 05/2012
Document Id: 7674ab62-f097-4b09-8c97-a448dceeacf9
Set id: 702f9786-7ce9-43e4-921d-e1db09612127
Version: 2
Effective Time: 20120515
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc