FDA label 3ac8c0a1-6080-4326-b5c6-312c552d5002

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
c73dbb97-5f08-4b19-8961-4304f64c3173
SPL ID
3ac8c0a1-6080-4326-b5c6-312c552d5002
Version
3
Effective date
2024-12-23
Source export date
2026-10-22
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/2026-10-22/e902d457a1761a44fd3a30c39db9aa876f06b0835423db5444f8d1a30fdfcfa1/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run
20261023T001338Z
Imported at
2026-10-23 01:41:21

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 Ask a doctor before use if you have ■ cough that occurs with too much phlegm (mucus) ■ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema When using this product ■ do not use more than directed Stop use and ask a doctor if ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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