FDA label 852e4837-5e63-ced6-e053-2a91aa0abaac

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
5529ff63-6458-4c4e-8145-74ad6b4666a8
SPL ID
852e4837-5e63-ced6-e053-2a91aa0abaac
Version
2
Effective date
2019-03-28
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:30:44

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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if you have a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor a cough with too much phlegm (mucus) a persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor When using this product Do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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