FDA label a52a73e3-c91e-43e0-8272-1d27d3c68d1c

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
379e4f12-e2be-484d-8ea7-d9294384d00c
SPL ID
a52a73e3-c91e-43e0-8272-1d27d3c68d1c
Version
2
Effective date
2016-01-22
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:33:32

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 Stop use and ask a doctor if Swelling, rash, or fever develop. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting occurs. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician. Keep out of reach of children under 3 years of age.

Reported adverse events (FAERS/openFDA)#

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