FDA label bc057a83-5e85-4a11-9664-528403279009

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
79955b96-8f8c-49bb-a415-88a9cbeae633
SPL ID
bc057a83-5e85-4a11-9664-528403279009
Version
2
Effective date
2012-06-18
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:41:41

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 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. Do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician. Ask a physician 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, persistent headache, rash, nausea, or vomiting. Sore mouth symptoms do not improve in 2 days. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children - beware of accidental ingestion

Reported adverse events (FAERS/openFDA)#

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