FDA label 5cfc6ff0-661e-092e-e063-6294a90aa28f

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
7e8196ec-6695-40b0-a212-e14e9bb606fa
SPL ID
5cfc6ff0-661e-092e-e063-6294a90aa28f
Version
2
Effective date
2026-10-03
Source export date
2026-10-23
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/2026-10-23/a51739e93506c2ea49960d9d8b93613806ce6897e579b6294cbc5a7a56cff555/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
003b0607e7bf4d3ce17ccc0942e221303b4f62b17a6a00c54547eda454293380
Import run
20261026T035824Z
Imported at
2026-10-26 04:14:21

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: for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease ask your doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid When using this product drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness 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 a serious underlying medical illness If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Reported adverse events (FAERS/openFDA)#

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