FDA label 44da2864-7d5d-422a-a737-2e88ceb81e5b

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
9e70ead1-479f-48bb-9be4-a8b30b784795
SPL ID
44da2864-7d5d-422a-a737-2e88ceb81e5b
Version
4
Effective date
2020-07-20
Source export date
2026-11-06
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:05:55

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 with other antihistamines Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use i jnm f you are taking sedatives or tranquilizers When using this product avoid alcoholic beverages 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. In case of accidental 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.