FDA label 47d4075a-8c1d-f807-e063-6294a90a1f7c

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
eaf11ba7-b0e2-a422-e053-2995a90ae2a9
SPL ID
47d4075a-8c1d-f807-e063-6294a90a1f7c
Version
3
Effective date
2026-01-07
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:58:02

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 if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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 a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes mellitus 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. A persistent cough may be a sign of a serious condition.  new symptoms occur Keep this and all drugs out of the reach of children In case of accidental overdose, get medical help or contact a Poison Control Center immediately. When using this product  excitability may occur, especially in children  may cause marked drowsiness  avoid alcoholic drinks  alcohol, sedatives, and tranquilizers may increase the drowsiness effect  be careful when driving a motor vehicle or operating machinery Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. If pregnant or breastfeeding ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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