FDA label 15f1ed5b-6aff-78e8-e063-6394a90a3308

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
15f1ab1d-bd78-3691-e063-6294a90a9d9c
SPL ID
15f1ed5b-6aff-78e8-e063-6394a90a3308
Version
1
Effective date
2024-04-12
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 02:43:08

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 use with any other product containing diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma ? a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks excitability may occur, especially in children ? alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Reported adverse events (FAERS/openFDA)#

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