BENADRYL ALLERGY  QUICK DISSOLVE - diphenhydramine hydrochloride strip 
McNeil Consumer Healthcare Division of 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 film strip)

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
  • place one film strip on tongue and allow it to dissolve. A second film strip may be taken after the first strip has dissolved.
children 6 to 11 years
  • place one film strip on tongue and allow it to dissolve.
children under 6 yearsdo not use this product in children under 6 years of age

Other information

Inactive ingredients

acesulfame potassium, carrageenan, FD&C blue #2 aluminum lake, flavors, glycerin, glyceryl oleate, locust bean gum, medium chain triglycerides, polysorbate 80, povidone, propylene glycol, pullulan, sodium polystyrene sulfonate, sucralose and xanthan gum.

Questions or comments?

call 1-877-717-2824

PRINCIPAL DISPLAY PANEL

NDC 50580-337-10

ON-THE-GO

Benadryl®

ALLERGY

QUICK DISSOLVE STRIPS

Diphenhydramine HCl | Antihistamine

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

10 STRIPS 25 MG EACH
VANILLA MINT

LIFT HERE FOR
DRUG FACTS

Principal Display Panel

BENADRYL ALLERGY   QUICK DISSOLVE
diphenhydramine hydrochloride strip
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-337
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
carrageenan 
FD&C blue NO. 2 
aluminum oxide 
glycerin 
glyceryl oleate 
locust bean gum 
caprylic/capric mono/diglycerides 
polysorbate 80 
povidones 
propylene glycol 
pullulan 
sodium polystyrene sulfonate 
sucralose 
xanthan gum 
Product Characteristics
ColorGREEN (Green to Blue) Score    
ShapeSize42mm
FlavorVANILLA (Vanilla Mint) Imprint Code WL;25
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:50580-337-1010 POUCH in 1 CARTONcontains a POUCH
11 STRIP in 1 POUCHThis package is contained within the CARTON (50580-337-10)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/200908/31/2011

Labeler - McNeil Consumer Healthcare Division of McNeil-PPC, Inc. (878046358)

Revised: 10/2012 McNeil Consumer Healthcare Division of McNeil-PPC, Inc.