FDA label 1958ebfa-047e-4947-bcc9-a5769bff0192

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
1825d1c0-2950-43ca-adc7-3aa1ce50a813
SPL ID
1958ebfa-047e-4947-bcc9-a5769bff0192
Version
1003
Effective date
2021-11-10
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:18

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 Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to enlargement of the prostate gland Do not use with any other product containing diphenhydramine, including products used topically. Ask a doctor or pharmacist before use if you are • taking tranquilizers or sedatives • taking other products containing diphenhydramine When using this product • Do not exceed recommended dosage • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • use caution when driving a motor vehicle or operating machinery If pregnant or breastfeeding ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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