FDA label 94233c3d-919a-4364-94cb-9e57a1b16166

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
a61a64b0-737c-4152-9568-377f52f09248
SPL ID
94233c3d-919a-4364-94cb-9e57a1b16166
Version
6
Effective date
2022-08-03
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:55

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 if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other product containing diphenhydramine, even one used on skin (Nighttime only) Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis (Nighttime only) glaucoma (Nighttime only) Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. ( Nighttime only ) When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) Stop use and ask a doctor if symptoms do not improve within 7 days or occur with fever nervousness, dizziness, or sleeplessness occur 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. If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

Reported adverse events (FAERS/openFDA)#

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