FDA label 7a2017b6-63ba-4f0f-9f7c-ffc60535f6ed

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
7b669688-76ea-4ac9-9fae-d382505bc659
SPL ID
7a2017b6-63ba-4f0f-9f7c-ffc60535f6ed
Version
3
Effective date
2016-08-23
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:50:08

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 physician or Poison Control Center right away. If pregnant or breast-feeding , seek advice of 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 or 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 physician.

Reported adverse events (FAERS/openFDA)#

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