FDA.reportPublic FDA data

FDA label 953919df-4cfa-4564-ac2c-c9ee84305fa5

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
a3b34f38-87da-4a38-ac73-66d28cc8647e
SPL ID
953919df-4cfa-4564-ac2c-c9ee84305fa5
Version
2
Effective date
2021-10-15
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 05:58:24

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: Do not use: in child who is taking a prescription monoamine oxidase inhibitor (MAOI), (certain drugs for prescription, psychiatric, or emotional conditions, or Parkinson's Disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. May cause excitability especially in children. Do not take this product, if you have a breathing problem such as emphysema or chronic bronchitis, glaucoma, heart disease, high blood pressure, diabetes, or thyroid disease, unless directed by a doctor. May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

Reported adverse events (FAERS/openFDA)#

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