FDA label 22f55264-cec3-4ddb-bef5-ab614297437d

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
5ced2ba5-4a79-4b9b-b949-5c0bcec9cdaa
SPL ID
22f55264-cec3-4ddb-bef5-ab614297437d
Version
4
Effective date
2018-12-26
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:50:16

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 give to children under 12 years of age. Do not use this product with other products containing diphenhydramine, even one used on skin. Ask a doctor before use if you have emphysema chronic bronchitis glaucoma difficulty in urination due to an enlargement of the prostate gland Ask a doctor or pharmacist before use if you are now taking sedatives or tranquilizers. When using this product avoid alcoholic beverages. Stop use and ask a doctor if sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

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