FDA label e034944b-7287-487f-9815-1e59a256a37a

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
f68bea6b-a5e8-4911-9d92-4f384db2114f
SPL ID
e034944b-7287-487f-9815-1e59a256a37a
Version
2
Effective date
2017-11-19
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:20

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: Severe or persistent sore throat or sore throat accompanied by fever, headache, rash, swelling, nausea, or vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age. When using this product do not use more than directed Stop use and ask a doctor if • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash or fever develops • difficulty in breathing occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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