FDA label 17b6e38f-fda2-4a18-8e06-063eee214575

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
6d54ef1e-6722-43f9-a0a7-14a786160b04
SPL ID
17b6e38f-fda2-4a18-8e06-063eee214575
Version
4
Effective date
2025-11-10
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:31:43

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 if you 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product • do not exceed recommended dosage • may cause drowsiness • alcohol, sedatives, and tranquilizers may increase the drowsiness effect • avoid alcoholic beverages • use caution when driving a motor vehicle or operating machinery marked may occur • excitability may occur especially in children Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. • symptoms do not improve within 7 days or are accompanied by fever If pregnant or breastfeeding 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.