Oxymetazoline Hydrochloride 12-Hour

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
Oxymetazoline Hydrochloride 12-Hour
Generic name
OXYMETAZOLINE HYDROCHLORIDE
Manufacturer
Sun Pharmaceutical Industries, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
34a79f8b-32b7-48db-a895-c942cc795292
SPL ID
56bb5577-e3d4-ae0b-e063-6394a90ab52c
Version
4
Effective date
2026-07-16
Source export date
2026-08-01
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/286b06ef66f7efdb8cdf48688678b429950d1b94558fe44fcd6cc6eb20c2100b/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:04:45
Harmonized routes table
Harmonized routes
NASAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not exceed recommended dosage This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection. Do not use for more than 3 days Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland When using this product frequent or prolonged use may cause nasal congestion to recur or worsen Stop use and ask a doctor if symptoms persist 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.