FDA label 98523a35-7e1e-4c58-8a4b-62b0bdcf1b9a

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
eb9a9f9c-4dec-4791-bb1b-939a736f201b
SPL ID
98523a35-7e1e-4c58-8a4b-62b0bdcf1b9a
Version
2
Effective date
2011-07-29
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:51

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: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These symptoms may be serious. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm (mucus) When using this product do not exceed recommended dosage Stop use and consult a doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore throat is severe, or irritation, pain or redness lasts or worsens sore mouth does not improve in 7 days If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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