FDA label 8f4901fb-a70e-4001-9967-50372e7e3ea1

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
4f4aa9b1-c609-4928-85b4-2ca823c30d24
SPL ID
8f4901fb-a70e-4001-9967-50372e7e3ea1
Version
2
Effective date
2017-11-25
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:50:07

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 • in children under 12 years of age • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks Stop use and ask a doctor if sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of 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.

Reported adverse events (FAERS/openFDA)#

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