FDA label bdcee84a-2613-400a-a813-8ba860ed66c0

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
0c2632f4-edbc-47d4-94ef-af3512520596
SPL ID
bdcee84a-2613-400a-a813-8ba860ed66c0
Version
1
Effective date
2014-04-23
Source export date
2026-09-28
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/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:22:42

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 . If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor. 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. A persistent cough may be the sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately . Keep this and all drugs out of the reach of children .

Reported adverse events (FAERS/openFDA)#

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