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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

NAPHAZOLINE: 33 Adverse Event Reports & Safety Profile

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33
Total FAERS Reports
0
Deaths Reported
3
Hospitalizations
33
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Wal-Mart Stores Inc
Manufacturer
Discontinued
Status
Yes
Generic Available

Active Ingredient: NAPHAZOLINE HYDROCHLORIDE · Route: OPHTHALMIC · Manufacturer: Wal-Mart Stores Inc · FDA Application: 040073 · HUMAN OTC DRUG · FDA Label: Available

First Report: 2013 · Latest Report: 20240811

What Are the Most Common NAPHAZOLINE Side Effects?

#1 Most Reported
Eye irritation
8 reports (24.2%)
#2 Most Reported
Drug ineffective
6 reports (18.2%)
#3 Most Reported
Eye pain
5 reports (15.2%)

All NAPHAZOLINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Eye irritation 8 24.2% 0 0
Drug ineffective 6 18.2% 0 1
Eye pain 5 15.2% 0 0

Who Reports NAPHAZOLINE Side Effects? Age & Gender Data

Gender: 66.7% female, 33.3% male. Average age: 56.9 years. Most reports from: US. View detailed demographics →

Is NAPHAZOLINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 2 0 0
2014 1 0 0
2015 3 0 1
2016 1 0 0
2018 1 0 0
2019 1 0 0
2022 2 0 0
2023 3 0 0
2024 2 0 0

View full timeline →

What Is NAPHAZOLINE Used For?

IndicationReports
Product used for unknown indication 13

Official FDA Label for NAPHAZOLINE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Use First remove the protective cap, before first use, press several times until liquid squirts out, then insert the nozzle into the nostril, press firmly, pull the nozzle out of the nostril before releasing, then release, close the cap for protection.

Dosage & Administration

Directions Adults&children 12 years &older(with adult supervision ): 2 or 3 sprays in each nostril,not more often than every 10 to 12 hours. Do not exceed 2 doses in 24 hours. Ask a doctor: children 6 to under 12 years. Do not use children under 6 years Shake well before use. Before using the first time, remove the protective cap &safely clip from the tip and prime metered pump by depressing firmly severaltimes. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depresspump all the way down with a firm even stroke and sniff deeply. Wipe nozzleclean after use.

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.

Active Ingredient

Active ingredients Purpose Naphazoline hydrochloride 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine

Inactive Ingredients

Inactive ingredients Water, Glycosyl Trehalose, Schizophyllan, Citrus Reticulata (Tangerine)

Fruit

Extract, Benzyl Alcohol, Polysorbate 80, Sodium Citrate, Rhamnose, Carboxymethyl Chitosan, Phenoxyethanol, Disodium Edta, Benzoic Acid