FDA.reportPublic FDA data

Naphazoline HCI And Pheniramine Maleate

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Naphazoline HCI And Pheniramine Maleate
Generic name
NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE
Manufacturer
Altaire Pharmaceuticals Inc.
Product type
HUMAN OTC DRUG
SPL set ID
5649c6e2-966f-44d9-b57e-5bb988eb373d
SPL ID
b78fd969-ee4c-0ea0-e053-2a95a90a480d
Version
4
Effective date
2020-12-28
Source export date
2026-08-17
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/1b5caad1d26c65d5be0ee71b8eb1373f0c7d99e6d83d2bfe99382f282ec02e02/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:36:40
Harmonized routes table
Harmonized routes
OPHTHALMIC

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a physician. Do not use in children under 6 years of age unless directed by a physician. If this solution changes color or becomes cloudy, do not use. Overuse of this product may produce increased redness of the eye. If you are sensitive to any ingredient in this product, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using.