Home FDA labels a4e542fa-307a-422c-b70d-63578f304217 FDA label a4e542fa-307a-422c-b70d-63578f304217 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 fee6fe7b-0e3c-4670-b993-3995c2b81cd2
SPL ID a4e542fa-307a-422c-b70d-63578f304217
Version 1
Effective date 2012-03-30
Source export date 2026-10-12
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:22:48 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.
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 If symptoms persist or worsen, consult a physician. If pregnant or nursing, take only on advice of healthcare professional. Other Tamper resistant for your protection. Use only if safely seal is intact. Reference image: colic relief.jpg
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.