FDA.reportPublic FDA data

FDA label ccc4521a-325d-4fb9-a1b3-db9695280d90

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
87427040-c687-4068-8418-4776330f624e
SPL ID
ccc4521a-325d-4fb9-a1b3-db9695280d90
Version
1
Effective date
2012-11-14
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:06:28

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 Do not use if outer package seal is broken. A persistent cough may be a sign of a serious condition. If a cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache, stop use and consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor. Consult a doctor before use in children younger than 8 years of age.

Reported adverse events (FAERS/openFDA)#

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