FDA label 3825f8b8-2e4c-4604-bc7f-cc3d99dd3938

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
1542f6e2-e0d2-44b9-be14-f304033342d1
SPL ID
3825f8b8-2e4c-4604-bc7f-cc3d99dd3938
Version
3
Effective date
2021-05-13
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:26

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 - ​Se•vere or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician. ​Stop use and ask doctor if: • Symptoms worsen ​•Any new symptoms appear. • Fever lasts for more than three days. • Respiratory symptoms persist for more than seven days. ​If pregnant or breast feeding ​, ask a health professional before using. ​Keep out of reach of children. ​In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children . In case of overdose, 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.