FDA label c55f94c7-947d-4001-bc8f-f0bbd17f55ea

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: 1de957e4-b0c9-4851-a19e-0537ce15b581
SPL ID: c55f94c7-947d-4001-bc8f-f0bbd17f55ea
Version: 2
Effective date: 2015-09-28
Source export date: 2026-10-12
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/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:03:29

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		c55f94c7-947d-4001-bc8f-f0bbd17f55ea	id
spl set id		1de957e4-b0c9-4851-a19e-0537ce15b581	set_id

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 persistant sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician. Caution: Not recommended for pregnant or lactating women.

Reported adverse events (FAERS/openFDA)#

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