FDA label 2dfe9515-b626-41d6-a129-5054814af76f

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
9de95fbd-e53c-41bc-9a88-819cbfb6f190
SPL ID
2dfe9515-b626-41d6-a129-5054814af76f
Version
1
Effective date
2014-04-23
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:21:57

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 take this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not use if you are now 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. 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 smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. If pregnant or breast-feeding, ask a health professional before use . 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.