FDA label 15fda7d2-4b50-4493-bbcf-945f92f78f3c

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
87b442b6-de88-4f53-a54a-542f7d97cea1
SPL ID
15fda7d2-4b50-4493-bbcf-945f92f78f3c
Version
2
Effective date
2012-06-18
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:21:21

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 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, 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.