FDA Label for Visine Allergy Eye Relief Multi-action

View Indications, Usage & Precautions

Visine Allergy Eye Relief Multi-action Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose



Active ingredientsPurpose
Naphazoline HCl 0.025%Redness reliever
Pheniramine maleate 0.3%Antihistamine

Uses



Temporarily relieves itchy, red eyes due to:

  • pollen
  • ragweed
  • grass
  • animal hair and dander

Warnings



For external use only


Otc - Do Not Use



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

When Using This Product



  • pupils may become enlarged temporarily causing light sensitivity
  • 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
  • some users may experience a brief tingling sensation

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

Otc - Keep Out Of Reach Of Children



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 4 times a day
  • children under 6 years of age: consult a doctor

Other Information



  • Store at 15° to 25°C (59° to 77°F)

Inactive Ingredients



benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium hydroxide and/or hydrochloric acid


Questions?



call toll-free 888-734-7648 or 215-273-8755 (collect)


Other



Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558


Principal Display Panel - 15 Ml Bottle Carton



VISINE®

NAPHAZOLINE HCl 0.025%
AND PHENIRAMINE MALEATE 0.3%
OPHTHALMIC SOLUTION
ANTIHISTAMINE AND REDNESS RELIEVER

ALLERGY EYE RELIEF
MULTI-ACTION

ORIGINAL
PRESCRIPTION STRENGTH

Clinically Proven to
Relieve Red,
Itchy Eyes

STERILE
EYE DROPS

1/2 FL OZ (15mL)


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