FDA label d5617c61-e771-4a49-ad2e-3703118a154c

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: eaa71305-0df5-49f4-85d5-de2b8dc68d3d
SPL ID: d5617c61-e771-4a49-ad2e-3703118a154c
Version: 2
Effective date: 2013-02-14
Source export date: 2026-11-06
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:58:16

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		d5617c61-e771-4a49-ad2e-3703118a154c	id
spl set id		eaa71305-0df5-49f4-85d5-de2b8dc68d3d	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

Warnings If cough persists more than 7 days, or is accompanied by fever, rash, or persistent headache, stop use and consult physician. Note: A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. Other information: Tamper resistant for your protection. Use only if safety seal is intact.

Reported adverse events (FAERS/openFDA)#

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