Home FDA labels 8503ad98-0f75-2a2d-e053-2a91aa0aa36a FDA label 8503ad98-0f75-2a2d-e053-2a91aa0aa36a 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 7732e28c-5643-bcf9-e053-2991aa0a42ff
SPL ID 8503ad98-0f75-2a2d-e053-2a91aa0aa36a
Version 2
Effective date 2019-03-26
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 06:30:35 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 DO NOT USE: •if allergic to sulfites •on children under 2 years of age unless directed by a doctor •with any other products containing diphenydramine, even one taken by mouth •on deep puncture wounds, animal bites or serious burns unless directed by a doctor •on large areas of the body
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.