Visine amulti-action eye allergy relief solution/ drops

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

Active ingredients Purpose
Naphazoline HCl 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

For external use only

Otc - do not use section

Do not useif 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

Otc - keep out of reach of children section

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 at 15 to 25C (59 to 77F)

Inactive ingredients

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

Questions?

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

Caution

Do not use if VISINE ®imprinted neckband on bottle is broken or missing.

Ingredients and appearance - Product information

Visine amulti-action eye allergy relief solution/ drops- Naphazoline hydrochloride and pheniramine maleate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 42002-200
Route of Administration Ophthalmic

Active Ingredient/Active Moiety

Ingredient Name Strength
Naphazoline hydrochloride ( UNII: MZ1131787D)( Naphazoline - UNII: H231GF11BV ) 0.25 mgin 1 mL
Pheniramine maleate ( UNII: NYW905655B)( Pheniramine - UNII: 134FM9ZZ6M ) 3 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Boric acid ( UNII: R57ZHV85D4)
Sodium borate ( UNII: 91MBZ8H3QO)
Benzalkonium chloride ( UNII: F5UM2KM3W7)
Edetate disodium ( UNII: 7FLD91C86K)
Sodium hydroxide ( UNII: 55X04QC32I)
Hydrochloric acid ( UNII: QTT17582CB)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA020485 USA

Labeler - Johnson & Johnson Consumer Inc.( 002347102)

Principal display panel - 15 ml bottle carton

Sterile
Visine ®-A ®
PHENIRAMINE MALEATE 0.3%
NAPHAZOLINE HYDROCHLORIDE 0.025%

ANTIHISTAMINE + REDNESS
RELIEVER EYE DROPS

MULTI-ACTION
EYE
ALLERGY
Relief

Clinically
proven to
relieve itchy,
red, allergy
eyes

1/2 FL OZ (15 mL)