FDA label fc10a9ab-b0a8-288f-e053-6394a90a1082

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
5bbbb3f0-40bc-4dee-b352-a834a4a09908
SPL ID
fc10a9ab-b0a8-288f-e053-6394a90a1082
Version
8
Effective date
2023-05-19
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:04:10

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 THIS PRODUCT TO SEDATE CHILDREN Do not use: more than the recommended dosage. if you are 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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, or if cough is accompanied by excessive phlegm (mucus). difficulty in urination due to enlargement of the prostate gland. glaucoma. thyroid disease. When using this product may cause drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. If you are taking sedatives or tranquilizers, consult your doctor before taking this medicine. Use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if cough lasts more than seven days, returns or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, Do Not Use. Keep out of reach of children. In case of accidental 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.