FDA label 697d0e68-c4c4-4b24-a155-1c2d8310ef31

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
40630bad-d8ce-47a9-aa13-737e10a1e7e0
SPL ID
697d0e68-c4c4-4b24-a155-1c2d8310ef31
Version
2
Effective date
2015-01-08
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:20

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 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product Ask a doctor before use if a child has a breathing problem such as emphysema or chronic bronchitis glaucoma a persistent or chronic cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus Ask a doctor or pharmacist before use if a child is taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase drowsiness effect Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately. 1-800-222-1222

Reported adverse events (FAERS/openFDA)#

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