FDA label c3464ade-e54f-4b64-b347-c1b5ecfae7f8

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
5375b99c-ad91-409f-850d-9ea0003b32d3
SPL ID
c3464ade-e54f-4b64-b347-c1b5ecfae7f8
Version
5
Effective date
2012-12-01
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 05:12:58

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For external use only Do not use on more than directed on large areas of the body with any other product containing diphenhydramine, even one taken by mouth on deep or puncture wounds on animal bites on serious burns on serious sunburn or broken, blistered or oozing skin Ask a doctor before use on chicken pox on measles When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, Ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

Warnings For external use only Do not use on more than directed on large areas of the body with any other product containing diphenhydramine, even one taken by mouth on deep or puncture wounds on animal bites on serious burns on serious sunburn or broken, blistered or oozing skin Ask a doctor before use on chicken pox on measles When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, Ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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