FDA label 0c868adb-9986-5c7a-e063-6394a90a6638

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
d053201d-9ae2-47c2-8f07-3e4b4af940b6
SPL ID
0c868adb-9986-5c7a-e063-6394a90a6638
Version
2
Effective date
2023-12-15
Source export date
2026-10-30
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-30/3b4c9bc1c064560160661a043b9878894ba805e5e90f4733fb76824b6ba7ac42/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run
20261102T182004Z
Imported at
2026-11-02 19:20:41

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 traouble urinating due to a to enlarged prostate gland glaucome Ask a doctor or pharmacist before useif you are taking Sedatives or tranquilizers When using this product avoid alcoholic drinks Stop use and ask a doctor if sleeplessness lasts continuosly 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.