FDA label ffde5fe1-c84d-4ccf-a417-36ff56b47790

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: 6566ea59-7a79-4fef-9986-1de0c7c4e8f3
SPL ID: ffde5fe1-c84d-4ccf-a417-36ff56b47790
Version: 4
Effective date: 2011-07-15
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:32:25

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		ffde5fe1-c84d-4ccf-a417-36ff56b47790	id
spl set id		6566ea59-7a79-4fef-9986-1de0c7c4e8f3	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

Ask a doctor before use if you have a cough that last or it is chronic such as occurs with smoking, asthma, chronic Bronchitis or emphysema. Stop use and ask doctor if a cough lasts for more than 7 days comes back or occurs when fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant of breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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