FDA label 946ca387-39b0-49a7-8972-ca53d568b279

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
31d96c3e-f5f2-41c2-865a-f49b910ddc77
SPL ID
946ca387-39b0-49a7-8972-ca53d568b279
Version
4
Effective date
2024-01-01
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:43:29

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 • to make a child sleepy • with any other product containing diphenhydramine, even one that is used on skin. Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland • glaucoma Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers When using this product • marked drowsiness may occur • avoid alcohol beverages • alcohol, sedatives and tranquilizers may increase the drowsiness effect • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in children If pregnant or breast feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, contact a physician or poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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