FDA label 0dad71fd-ec86-1bb3-e063-6294a90a911a

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
f128cb2e-bac8-316d-e053-2995a90a52b6
SPL ID
0dad71fd-ec86-1bb3-e063-6294a90a911a
Version
2
Effective date
2023-12-29
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:52:40

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.