FDA.reportPublic FDA data

FDA label 1a77d712-5486-414c-9490-0fae6bc44aa8

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
a5a17bd5-1d29-4d8e-ada7-1323ed69a39b
SPL ID
1a77d712-5486-414c-9490-0fae6bc44aa8
Version
4
Effective date
2016-08-18
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:57

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) or 5 days (children) unless directed by a doctor. If pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. Keep out of Reach of Children : Keep out of reach of children. Ask the Doctor: Do not take this product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor. If pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. 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.