FDA label 2434b630-ca13-42c9-8b41-37ed0868e4dd

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
c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5
SPL ID
2434b630-ca13-42c9-8b41-37ed0868e4dd
Version
2
Effective date
2023-01-16
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:55:19

Warnings cross-check#

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

Warnings sections page 1 of 2 · 6 matching rows.

warnings

WARNINGS Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin • this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland Ask a doctor before use if your 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfin When using this product • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children • avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery. Keep our of reach of children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

warnings

Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin • this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland

warnings

Ask a doctor before use if your child has • a breathing problem such as chronic bronchitis • glaucoma • a sodium-restricted diet

warnings

Ask a doctor or pharmacist before use if the child is • taking sedatives or tranquilizers

Reported adverse events (FAERS/openFDA)#

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