Your browser does not support JavaScript! BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]
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RxNorm Names

BENADRYL (diphenhydramine hydrochloride) tablet, film coated
[Lil' Drug Store Products, 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 15 mg
  • store between 20 - 25°C (68 - 77°F). Avoid high humidity. Protect from light.
  • do not use if carton or pouch is opened or torn
  • see bottom 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 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:66715-9706(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 
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:66715-9706-11 in 1 CARTON
12 in 1 POUCH
2NDC:66715-9706-22 in 1 CARTON
22 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/16/2010
Labeler - Lil' Drug Store Products, Inc. (093103646)

Revised: 12/2012
 
Lil' Drug Store Products, Inc.

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