FDA.reportPublic FDA data

FDA label c0f53a8c-00a8-2214-e053-2995a90a5397

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
27b1977b-ba86-47aa-976d-c5769a7e4b39
SPL ID
c0f53a8c-00a8-2214-e053-2995a90a5397
Version
3
Effective date
2021-04-27
Source export date
2026-08-01
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/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:16:22

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 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 sore throat is severe or persists more than 2 days accompanied by headache, nausea, and vomiting, contact a doctor right away. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Keep out of reach of children.