FDA label 53c2be18-f690-4d71-badd-6d886ba126b9

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
ba807ce6-2ef4-4fd9-b312-beeaefe56c97
SPL ID
53c2be18-f690-4d71-badd-6d886ba126b9
Version
14
Effective date
2014-06-25
Source export date
2026-10-22
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/2026-10-22/14398cbe7e22245154b804e51e14ec487486e2bb68b514fde0d7c34660e837f0/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run
20261023T001338Z
Imported at
2026-10-23 00:31:27

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 give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if your child has heart diseases high blood pressure thyroid disease diabetes glaucoma asthma a breathing problem or a persistent or chronic cough excessive phlegm (mucus) cough that occurs with too much phlegm (mucus) chronic bronchitis Ask a doctor or pharmacist before use if your child is taking sedatives or tranquilizers When using this product your child may become easily excited get drowsy sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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 right away.

Reported adverse events (FAERS/openFDA)#

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