FDA label 055f176d-aaf2-4e2d-b377-6fb2615ebc3e

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
42c8fac1-8afe-4278-94c2-7363f732a4bf
SPL ID
055f176d-aaf2-4e2d-b377-6fb2615ebc3e
Version
2
Effective date
2015-01-07
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:40:04

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 Do Not Use if you or your child are taking sedatives or tranquilizers, without first consulting your doctor if you or your child are now 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 taking this product. Ask a doctor before use if your child has glaucoma a breathing problem such as emphysema or chronic bronchitis a persistent or chronic cough that occurs with too much phlegm (mucus) heart disease high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery 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, rash, or headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. Overdose warning 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.