Your browser does not support JavaScript! BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]
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RxNorm Names

BENADRYL (diphenhydramine hydrochloride) tablet, film coated
[McNeil Consumer Healthcare Div McNeil-PPC, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

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

  • 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

  • take every 4 to 6 hours, or as directed by a doctor
  • 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

Other information

  • each tablet contains: calcium 20 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

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) or visit www.benadryl.com

PRINCIPAL DISPLAY PANEL

NDC 50580-226-52

Benadryl®

ALLERGY

Diphenhydramine HCl 25 mg | Antihistamine

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

ULTRATABS™*
*small tablet size

48 TABLETS

Principal Display Panel
BENADRYL  
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-226
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax 
Crospovidone 
Croscarmellose Sodium 
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 DescriptionMarketing Start DateMarketing End Date
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:50580-226-532 in 1 POUCH
9NDC:50580-226-551 in 1 CARTON
9148 in 1 BOTTLE
10NDC:50580-226-524 in 1 CARTON
1012 in 1 BLISTER PACK
11NDC:50580-226-563 in 1 PACKAGE
11NDC:50580-226-524 in 1 CARTON
1112 in 1 BLISTER PACK
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: 8/2013
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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