FDA label dfd5bb3e-5649-4559-9e32-fbffc7d13337

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
3f6988df-a596-41f1-b2be-64f8e4b55885
SPL ID
dfd5bb3e-5649-4559-9e32-fbffc7d13337
Version
1
Effective date
2024-07-01
Source export date
2026-08-01
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/928e480b2a9ec5fd356ebc3e5dcca70f0f57b8a051cfbb174a4421de39bb77a2/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:24:20

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 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 bronchi Ask a doctor or pharmacist before use if you are • taking sedative 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 machine If pregnant or breast-feeding, ask a health professional before use.