naphazoline hydrochloride and pheniramine maleate

FDA Drug Profile — Naphcon A

Drug Details

Generic Name
naphazoline hydrochloride and pheniramine maleate
Brand Names
Naphcon A
Application Number
NDA020226
Sponsor
A-S Medication Solutions
NDC Codes
2
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE

Indications and Usage

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

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.