FDA label d667dc25-66f6-4b08-88da-0dcc82475306

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
ed7a3bdc-fe85-4ebf-bd94-6b43a512eff7
SPL ID
d667dc25-66f6-4b08-88da-0dcc82475306
Version
4
Effective date
2021-12-16
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:04:28

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 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 of breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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