FDA label 34385375-1c3e-5ecd-e054-00144ff8d46c

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
34385375-1c3d-5ecd-e054-00144ff8d46c
SPL ID
34385375-1c3e-5ecd-e054-00144ff8d46c
Version
1
Effective date
2016-06-01
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:30:50

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, and vomiting may be serious. Consult dentist or doctor promptly. • Do not use more than 2 days or administer to children under 3 years of age unless directed by a dentist or doctor. • Discontinue use and consult a dentist or doctor if irritation persists or increases, or a rash appears or you are allergic to this product. • Try to avoid swallowing this product. • If large quantity is accidentally swallowed, get medical help or contact a Poison Control Center right away. • Keep out of reach of children. • If pregnant or breast-feeding, consult a dentist or doctor before use.

Reported adverse events (FAERS/openFDA)#

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