FDA label 5549489c-a05d-43a4-b94a-e73a92248685

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)

SPL set ID: 1b379002-e777-43a1-8b44-1ce7055979d0
SPL ID: 5549489c-a05d-43a4-b94a-e73a92248685
Version: 2
Effective date: 2012-06-19
Source export date: 2026-10-12
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/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:04:52

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		5549489c-a05d-43a4-b94a-e73a92248685	id
spl set id		1b379002-e777-43a1-8b44-1ce7055979d0	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

RISK INFORMATION: CONSULT A HEALTH CARE PRACTITIONER IF SYMPTOMS PERSIST OR WORSEN, IF SORE THROAT SYMPTOMS ARE SEVERE OR PERSIST FOR MORE THAN TWO DAYS, IF COUGH WORSENS, PERSISTS FOR MORE THAN SEVEN DAYS OR IS ACCOMPANIED BY HIGH FEVER. CONSULT A HEALTH CARE PRACTITIONER PRIOR TO USE IF YOU TAKE IMMUNOSUPPRESSANTS OR HAVE A PROGRESSIVE SYSTEMIC DISEASE SUCH AS TUBERCULOSIS, LEUKOSIS, COLLAGENOSIS OR MULTIPLE SCLEROSIS.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.