FDA.reportPublic FDA data

FDA label 80f3dfc4-e4a9-44a1-a2de-074469b953d6

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
e92a5899-f503-43f4-9651-1adbd57227a3
SPL ID
80f3dfc4-e4a9-44a1-a2de-074469b953d6
Version
1
Effective date
2012-12-05
Source export date
2026-08-08
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/13477f292fde418ab8b889dedaeed5fd633628cccdf0fe6d78a20f4b857aa1ee/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 17:36:51

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 A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. If breast-feeding or pregnant, consult your physician before using. Keep this and all drugs out of the reach of children.