FDA label f5c05aa5-6b4c-4a6c-ba9b-2fe1cc8bce03

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
a525d0c3-6526-4cb1-a3a3-f434119b6826
SPL ID
f5c05aa5-6b4c-4a6c-ba9b-2fe1cc8bce03
Version
1
Effective date
2011-04-01
Source export date
2026-10-30
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/2026-10-30/9abf0f8b126f8aad070e21ea702bfb5e39ce670b16ae57dd52e8877705d1bf5d/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run
20261102T182004Z
Imported at
2026-11-02 19:34:08

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. Do not give to children under 5 years of age unless directed by a doctor. 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) Stop use and ask a doctor if: cough lasts more than 1 week, tends to reoccur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore mouth does not improve in 7 days irritation, pain or redness persists or worsens If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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