FDA label 735ba7bd-a1b7-4c4b-89e3-5109a6233cea

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
84d8fa30-9c31-4994-8ea1-b1eea336b20a
SPL ID
735ba7bd-a1b7-4c4b-89e3-5109a6233cea
Version
3
Effective date
2012-06-19
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:21:22

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 Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. A persistent cough may be a sign of a serious condition. 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: Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache 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.