Home FDA labels 4924194e-5c66-4af3-b83a-5367a10248a2 FDA label 4924194e-5c66-4af3-b83a-5367a10248a2 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 dac2e27b-126b-4773-9e8e-5186ca9965fa
SPL ID 4924194e-5c66-4af3-b83a-5367a10248a2
Version 6
Effective date 2014-08-14
Source export date 2026-10-12
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:47:48 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 Ask a doctor before use if you have a breathing problem such as chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Do not use to make a child sleepy Do not use with any other product containing diphenhydramine, even one used on skin
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.