FDA label cfd4ca03-bbbf-3f6c-e053-2995a90aa2d9

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
93e0411b-68c2-4b5c-aa74-b1d94b5b2206
SPL ID
cfd4ca03-bbbf-3f6c-e053-2995a90aa2d9
Version
6
Effective date
2021-11-02
Source export date
2026-08-01
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:08:31

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 giving 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 prostrate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not exceed recommended dosage marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery excitability may occur especially in children Stop use and ask a doctor if symptoms do not improve within 7 days or are accompanied by fever nervousness, dizziness, or sleeplessness occur 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.