FDA label 6e47bb4d-af0e-4217-9ab8-765e63f2d644

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
9d5f7d8b-2447-44b6-9304-497a99c94ea4
SPL ID
6e47bb4d-af0e-4217-9ab8-765e63f2d644
Version
2
Effective date
2011-08-23
Source export date
2026-10-12
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/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:37

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 exceed recommended dosage. Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, 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 Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by a fever new symptoms occur Keep out of the reach of children. In case of accidental 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.