FDA label fce51964-2419-4b92-9f33-d91df2d26dc1

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: 0dafe4a4-bcd3-4b8e-872a-fb981cd52d50
SPL ID: fce51964-2419-4b92-9f33-d91df2d26dc1
Version: 3
Effective date: 2017-03-09
Source export date: 2026-10-12
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:07:13

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		fce51964-2419-4b92-9f33-d91df2d26dc1	id
spl set id		0dafe4a4-bcd3-4b8e-872a-fb981cd52d50	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: Do not take this product for pain for more than 10 days (adult) and 5 days (children) unless directed by a doctor. If pain persists or get worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. Children: Keep out of reach of children. Pregnancy or Breast Feeding: If pregnant or breast-feeding, ask a healthcare professional before use.

Reported adverse events (FAERS/openFDA)#

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