FDA label 6c3654f8-5829-4200-921b-e8e058c0c7b0

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
ef8abf4f-ce65-45c9-9df2-23e673c13756
SPL ID
6c3654f8-5829-4200-921b-e8e058c0c7b0
Version
2
Effective date
2024-12-06
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:27:32

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 if you are now taken a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease trouble urinating due to enlarged prostate gland glaucoma cough that occurs with too much phlegm(mucus) a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. Stop using this product and ask a doctor if you get nervous, dizzy or sleepless cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headaches, these could be signs of a serious condition. When using this product Excitability may occur, especially in children May cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect Avoid alcoholic beverages while taking this product Use caution when driving motor vehicle or operating machinery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults even if you do not notice signs or symptoms. If you are pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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