FDA label 39a97866-53a1-4f14-88f3-1a239df8f834

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
9a384e6f-f5b4-4daf-b268-d2d853eca002
SPL ID
39a97866-53a1-4f14-88f3-1a239df8f834
Version
3
Effective date
2026-09-09
Source export date
2026-10-23
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-23/be352910d55b2879306b6462ffbd43a3395f7ffd84abd47c54f922438f24b162/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
003b0607e7bf4d3ce17ccc0942e221303b4f62b17a6a00c54547eda454293380
Import run
20261026T035824Z
Imported at
2026-10-26 05:08:10

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 with any other product containing diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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