FDA label 4ab910e9-8b99-488c-8945-b5a6ae7a89e7

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
826c5868-c9bf-42b2-a97e-2e7ae6fae057
SPL ID
4ab910e9-8b99-488c-8945-b5a6ae7a89e7
Version
14
Effective date
2020-06-06
Source export date
2026-11-06
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:53:58

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 with any other product containing diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages excitability may occur, especially in children 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 (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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