FDA label 339d4cb3-73a1-7a14-e063-6394a90a6953

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
f3824e93-c4ff-0c9a-e053-2995a90a2fdf
SPL ID
339d4cb3-73a1-7a14-e063-6394a90a6953
Version
5
Effective date
2025-04-25
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:30

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

 to make a child sleepy  with any other product containing diphenhydramine, even one used on skin 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 if you are taking sedatives or tranquilizers When using this product  marked drowsiness may occur  avoid alcoholic drinks  alcohol, sedatives and tranquilizers may increase drowsiness  be careful when driving a motor vehicle or operating machinery  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 right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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