FDA label 558e1512-a310-d554-e063-6294a90a16d5

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
0ccbc301-6833-bbc4-e063-6294a90aad92
SPL ID
558e1512-a310-d554-e063-6294a90a16d5
Version
2
Effective date
2026-06-29
Source export date
2026-10-30
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-30/9abf0f8b126f8aad070e21ea702bfb5e39ce670b16ae57dd52e8877705d1bf5d/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run
20261102T182004Z
Imported at
2026-11-02 19:30:31

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.