FDA label b971b647-2ccc-4e24-e053-2995a90a9246

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
31561793-6d6c-2abe-e054-00144ff8d46c
SPL ID
b971b647-2ccc-4e24-e053-2995a90a9246
Version
4
Effective date
2021-01-21
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:59:02

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings may cause excitability, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Do Not Use to make a child drowsy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if your child has glaucoma a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product do not use more than directed may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if: nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or are accompanied by a fever 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.

Reported adverse events (FAERS/openFDA)#

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