FDA label 46e119c4-d3aa-eefc-e063-6294a90a94f1

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
e2889673-a8aa-4cb1-ba52-fb94b7b057ab
SPL ID
46e119c4-d3aa-eefc-e063-6294a90a94f1
Version
2
Effective date
2025-12-26
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:28:46

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 doctor before use if you have • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema • cough is accompanied by excessive phlegm (mucus) Stop use and ask doctor if • Symptoms are accompanied by fever, rash or persistent headache • cough persists for more than 1 week or tends to recur A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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