FDA label 52ba4afa-7ab8-42b7-b19b-73fc79484646

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
66240ed0-8fd1-4b97-9c60-d282a0c9a19d
SPL ID
52ba4afa-7ab8-42b7-b19b-73fc79484646
Version
4
Effective date
2021-10-15
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:52

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 in a child who is 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 the child has heart disease high blood pressure diabetes thyroid disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with a fever, rash or headache that lasts. these could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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