Diphenhydramine Oral Liquid

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 Oral Liquid
Generic name
DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
Rising Pharma Holdings, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
d8462e6f-a9fb-4701-97e2-d81a47f3e196
SPL ID
952598aa-cb50-400d-85da-e8acab206e5a
Version
2
Effective date
2024-10-18
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 05:14:16
Harmonized routes table
Harmonized routes
ORAL

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 Do not use with any other product containing diphenhydramine, even one used on skin. Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis. a sodium-restricted diet 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. Directions take every 4-6 hours Do not use more than 6 dose in 24 hours adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 to 50 mg) children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 to 25 mg) children under 6 years ask a doctor

warnings table

<table width="50%"><colgroup><col width="45%" align="center" valign="middle"/><col width="55%" align="center" valign="middle"/></colgroup><tbody><tr styleCode="Botrule First"><td align="center">adults and children 12 years of age and over</td><td align="center">2 to 4 teaspoonfuls (25 to 50 mg)</td></tr><tr styleCode="Botrule"><td align="center">children 6 to under 12 years of age</td><td align="center">1 to 2 teaspoonfuls (12.5 to 25 mg)</td></tr><tr styleCode="Botrule Last"><td align="center">children under 6 years</td><td align="center">ask a doctor</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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