FDA label a00ca399-4cc5-4202-a05b-1eff68f241cd

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: 659c8a5e-eeb6-4872-aa7f-145b7fd2fb29
SPL ID: a00ca399-4cc5-4202-a05b-1eff68f241cd
Version: 4
Effective date: 2016-05-26
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 06:33:27

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		a00ca399-4cc5-4202-a05b-1eff68f241cd	id
spl set id		659c8a5e-eeb6-4872-aa7f-145b7fd2fb29	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: Keep out of reach of children. In case of overdose, contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use. Tamper Seal: "Sealed for Your Protection." Do not use if seal is broken or missing. WARNING: Severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by a physician.

Reported adverse events (FAERS/openFDA)#

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