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Name:Visine A
Manufacturer:Johnson & Johnson Healthcare Products, Division Of Mcneil-ppc, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Visine-A®

VISINE A - naphazoline hydrochloride and pheniramine maleate liquid 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

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Visine-A®

Drug Facts

Active ingredients Purpose
Naphazoline hydrochloride 0.025% Redness reliever
Pheniramine maleate 0.3% Antihistamine

Use

temporarily relieves itchy, red eyes due to:

  • pollen
  • ragweed
  • grass
  • animal hair and dander

Warnings

Do not use

  • if you are sensitive to any ingredient in this product

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • narrow angle glaucoma
  • trouble urinating due to an enlarged prostate gland

When using this product

  • pupils may become enlarged temporarily
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • overuse may cause more eye redness

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.

Directions

  • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to four times a day
  • children under 6 years of age: consult a doctor

Other information

  • some users may experience a brief tingling sensation
  • store between 15° and 25°C (59° and 77°F)

Inactive ingredients

boric acid and sodium borate buffer system preserved with benzalkonium chloride (0.01%) and edetate disodium (0.1%), sodium hydroxide and/or hydrochloric acid (to adjust pH), and purified water

Questions?

call 1-800-223-0182, weekdays

PRINCIPAL DISPLAY PANEL - 15 mL Carton

Sterile
Visine®-A®
PHENIRAMINE MALEATE 0.3%
NAPHAZOLINE HYDROCHLORIDE 0.025%
ANTIHISTAMINE & REDNESS
RELIEVER EYE DROPS

EYE
ALLERGY
Relief

Clinically
proven to
relieve itchy,
red, allergy
eyes due to
pollen, ragweed,
grass, animal
hair + dander

1/2 FL OZ (15 mL)

Principal Display Panel - 15 mL Carton

VISINE A 
naphazoline hydrochloride and pheniramine maleate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-200
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naphazoline Hydrochloride (Naphazoline) Naphazoline Hydrochloride 0.25 mg  in 1 mL
Pheniramine Maleate (Pheniramine) Pheniramine Maleate 3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Boric Acid  
Sodium Borate  
Benzalkonium Chloride  
Edetate Disodium  
Sodium Hydroxide  
Hydrochloric Acid  
Water  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42002-200-05 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (42002-200-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020485 02/01/2011

Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 01/2011 Johnson & Johnson Healthcare Products, 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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