FDA label 7c76c171-fcfd-4594-e053-2991aa0ac052

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
15862092-5cdc-3897-e054-00144ff88e88
SPL ID
7c76c171-fcfd-4594-e053-2991aa0ac052
Version
3
Effective date
2018-12-07
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:51:15

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

Diphenhydramine HCl 12.5 mg/5 mL Major Pharmaceuticals - IFU - For Institutional Use Only Warnings Do not use in neonates or premature infants if pregnant or breast-feeding if hypersensitive to diphenhydramine HCl and other similar antihistamines with any other product containing diphenhydramine, even one used on skin to make a child sleepy ___________________________________________________________________ Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis a sodium restricted diet trouble urinating due to an enlarged prostate gland ___________________________________________________________________ Ask a doctor or pharmacist before use if taking tranquilizers or sedatives ___________________________________________________________________ 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 ___________________________________________________________________

warnings

Diphenhydramine HCl 10 mg/ 10 mL Major Pharmaceuticals - For Institutional Use Only Warnings Do not use • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCl and other similar antihistamines • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy ___________________________________________________________________ Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • a sodium restricted diet • trouble urinating due to an enlarged prostate gland ___________________________________________________________________ Ask a doctor or pharmacist before use if • taking tranquilizers or sedatives ___________________________________________________________________ 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

Reported adverse events (FAERS/openFDA)#

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