Opcon-A

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE OPHTHALMIC HUMAN OTC DRUG

Opcon-A is an FDA drug label for the active ingredient NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE manufactured by Bausch & Lomb Incorporated administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231214.

Generic name
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
Manufacturer
Bausch & Lomb Incorporated
Product type
HUMAN OTC DRUG
Route
OPHTHALMIC
Dosage form
N/A
NDC
24208-430
Application
NDA020065
Label effective
20231214

Active ingredients

Active ingredients Naphazoline HCl (0.02675%) Pheniramine maleate (0.315%)

Indications & Usage

Uses • temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander

Dosage & Administration

Directions • Adults and children 6 years of age and older: Instill 1 or 2 drops in the affected eye(s) up to 4 times daily. • Children under 6 years: ask a doctor

Contraindications

Not available.

Warnings

Warnings For external use only Do not use • if you are sensitive to any ingredient in this product • if solution changes color or becomes cloudy Ask a doctor before use if you have • heart disease • high blood pressure • trouble urinating due to an enlarged prostate gland • narrow angle glaucoma When using this product • overuse may cause more eye redness • pupils may become enlarged temporarily • do not touch tip of container to any surface to avoid contamination • you may feel a brief tingling after putting drops in eye • replace cap after use • remove contact lenses before using Stop use and ask a doctor if you experience • eye pain • changes in vision • redness or irritation of the eye that worsens or lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

Adverse Reactions

Not available.

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