FDA label fc87a6a0-8a7a-acce-e053-6294a90a667e

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
acdd7406-9dc3-235f-e053-2a95a90a2df7
SPL ID
fc87a6a0-8a7a-acce-e053-6294a90a667e
Version
3
Effective date
2023-05-25
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:18:12

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 For External Use Only Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken pox or measles When using this product avoid contact with eyes Stop use and ask a doctor if Conditions worsen or do not improve within 7 days Symptoms persist for more than 7 days or clear up and occur again within a few days

Reported adverse events (FAERS/openFDA)#

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