FDA label fc55e4e8-393f-4c71-97cf-e06d247b6744

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
3ce70e8a-6a94-4dea-ab16-baf590fb2f08
SPL ID
fc55e4e8-393f-4c71-97cf-e06d247b6744
Version
3
Effective date
2012-06-18
Source export date
2026-08-01
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/f23e8214fa581dc87bce024b3f15739356a8bb6f9298e3d6be38c21c662a4211/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:06:15

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 Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. Consult a physician promptly. If symptoms are severe, do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician. Ask a doctor before use if you have: persistent or chronic cough associated with smoking, asthma, or emphysema. cough accompanied by excessive phlegm (mucus). Stop use and ask a doctor if: sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. sore mouth symptoms do not improve in 7 days. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.