FDA label 165a2e49-73d2-481f-b4ce-d6597c23e009

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
a6e94bea-7348-4b09-9244-9ef7b31a16b4
SPL ID
165a2e49-73d2-481f-b4ce-d6597c23e009
Version
2
Effective date
2016-06-15
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:06

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 • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin. • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have • a breathing problem such as asthma, emphysema, or chronic bronchitis • glaucoma • difficulty in urination due to enlargement of the prostate gland • heart disease Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid When using this product • avoid alcoholic beverages and other drugs that cause drowsiness • drowsiness will occur • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists 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. Overdose warning: Taking more than directed can cause serious health problems. 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.