Visine Allergy Eye Relief Multi-action Solution/ Drops
FDA Label NDC 69968-0367

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Visine Allergy Eye Relief Multi-action (NDC 69968-0367). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, otc - do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (15 mL Bottle Carton)

Principal Display Panel (15 mL Bottle Carton)

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