Visine® Allergy Eye Relief Multi-action

Visine® Allergy Eye Relief Multi-action
SPL v8
SPL
SPL Set ID 125fbc97-5bc8-436e-9ee9-e5a44384e260
Route
OPHTHALMIC
Published
Effective Date 2024-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naphazoline (0.25 mg) Pheniramine (3 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Edetate Disodium Water Sodium Borate Sodium Hydroxide Hydrochloric Acid

Identifiers & Packaging

Marketing Status
NDA Active Since 2019-05-06

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Temporarily relieves itchy, red eyes due to:

  • pollen
  • ragweed
  • grass
  • animal hair and dander
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50570-1

Do not use if you are sensitive to any ingredient in this product.

Section 55105-1
Active ingredients Purpose
Naphazoline HCl 0.025% Redness reliever
Pheniramine maleate 0.3% Antihistamine
Warnings

For external use only

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
Questions?

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

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

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
Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • narrow angle glaucoma
  • trouble urinating
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)


Structured Label Content

Uses

Temporarily relieves itchy, red eyes due to:

  • pollen
  • ragweed
  • grass
  • animal hair and dander
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50570-1 (50570-1)

Do not use if you are sensitive to any ingredient in this product.

Section 55105-1 (55105-1)
Active ingredients Purpose
Naphazoline HCl 0.025% Redness reliever
Pheniramine maleate 0.3% Antihistamine
Warnings

For external use only

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
Questions?

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

Other Information (Other information)
  • Store at 15° to 25°C (59° to 77°F)
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (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
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • narrow angle glaucoma
  • trouble urinating
Principal Display Panel 15 Ml Bottle Carton (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)


Advanced Ingredient Data


Raw Label Data

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