diphenhydramine hydrochloride

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)

Brand name
diphenhydramine hydrochloride
Generic name
DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
Simpex Pharma Pvt. Ltd
Product type
HUMAN OTC DRUG
SPL set ID
82771f6a-8b3d-4ffa-8b35-09c2faf3582c
SPL ID
0b586170-9b5f-74dc-e063-6394a90aa09b
Version
5
Effective date
2023-11-29
Source export date
2026-08-08
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/fb2175520ba436c0a81d623fd2a743c12c69c2188c898ffb9cc87c6b64d4a6cd/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:27:17
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin. Consult your doctor if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland. Consult your doctor if you are taking sedatives or tranquilizers sedative, 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 or reach of children. In case of overdose, get medical help or contact a poison control center right away. When using this product marked drowsiness may occur avoid alcoholic drinks.