Drugplain

Visine Red Eye Hydrating Comfort Eye Drops 10 mg/mL

TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400 · SOLUTION/ DROPS · Morning Star OTC

No Recall History
Plain English

Visine Red Eye Hydrating Comfort Eye Drops is a solution/ drops containing tetrahydrozoline hydrochloride and polyethylene glycol 400 at 10 mg/mL, taken ophthalmic. Manufactured by Morning Star OTC.

Key Facts

Brand Name
Visine Red Eye Hydrating Comfort Eye Drops
Generic Name
TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400
NDC Code (Product)
53209-6001
Manufacturer
Morning Star OTC
Strength
10 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
M018
Marketing Start
04/27/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

vision blurred2 reports
eye pruritus1 reports
poor quality product administered1 reports
product quality issue1 reports
product use complaint1 reports
scleral disorder1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the relief of redness of the eye due to minor eye irritations for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun for use as a protectant against further irritation or to relieve dryness of the eye

Dosage & Administration

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 children under 2 years of age: do not use

Warnings

Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma. When using this product pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using do not use if this solution changes color or becomes cloudy do not touch tip of container to any surface to avoid contamination replace cap after each use 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Visine Red Eye Hydrating Comfort Eye Drops used for?

Visine Red Eye Hydrating Comfort Eye Drops contains TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Visine Red Eye Hydrating Comfort Eye Drops a controlled substance?

Visine Red Eye Hydrating Comfort Eye Drops is not classified as a controlled substance by the DEA.

What is the generic name for Visine Red Eye Hydrating Comfort Eye Drops?

The generic name for Visine Red Eye Hydrating Comfort Eye Drops is TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400. There are 2 other brand versions of TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400.

What is the NDC code for Visine Red Eye Hydrating Comfort Eye Drops 10 mg/mL?

The NDC (National Drug Code) for Visine Red Eye Hydrating Comfort Eye Drops 10 mg/mL is 53209-6001, listed by Morning Star OTC.

Product NDC

53209-6001

Package NDC

53209-6001-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)