FDA label 108b7ac2-082d-47d4-a07d-58c50e40bb5c

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
92445b53-cd51-4bc8-9db9-cbc9d3ea9d4c
SPL ID
108b7ac2-082d-47d4-a07d-58c50e40bb5c
Version
1
Effective date
2014-02-16
Source export date
2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:12:25

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 children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drug that cause drowsiness such as antihistamines and nighttime cold/flu products Do not use with generic NyQuil® 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 You are taking a diuretic Ask a doctor or pharmacist before use if you are taking sedative 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 two weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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