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Name:Benadryl Allergy Quick Dissolve
Manufacturer:Mcneil Consumer Healthcare Division Of Mcneil-ppc, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Benadryl® ALLERGY QUICK DISSOLVE STRIPS

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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Benadryl®
ALLERGY
QUICK
DISSOLVE
STRIPS

Drug Facts

Active ingredient (in each film strip)

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

  • if needed, repeat dose every 4 to 6 hours
  • do not take more than 6 times in 24 hours
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 years do not use this product in children under 6 years of age

Other information

  • each film strip contains: sodium 4 mg
  • store at 59° - 77°F in a dry place. Protect from light.
  • do not use if individual carton or pouch is open or torn
  • see bottom panel for lot number and expiration date

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 Type HUMAN OTC DRUG Item Code (Source) NDC:50580-337
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
carrageenan  
FD&C blue NO. 2  
aluminum oxide  
glycerin  
glyceryl monooleate  
locust bean gum  
caprylic/capric mono/diglycerides  
polysorbate 80  
povidone  
propylene glycol  
pullulan  
sodium polystyrene sulfonate  
sucralose  
xanthan gum  
Product Characteristics
Color GREEN (Green to Blue) Score     
Shape Size 42mm
Flavor VANILLA (Vanilla Mint) Imprint Code WL;25
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50580-337-10 10 POUCH ( POUCH) in 1 CARTON contains a POUCH
1 1 STRIP ( STRIP) in 1 POUCH This package is contained within the CARTON (50580-337-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/01/2009

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

Revised: 01/2011 McNeil Consumer Healthcare Division of McNeil-PPC, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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