FDA label 6254de61-36f7-4839-9100-cf3d61ba962f

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
7d8ccd41-115f-4db7-a978-6775411c5f95
SPL ID
6254de61-36f7-4839-9100-cf3d61ba962f
Version
4
Effective date
2023-06-07
Source export date
2026-08-01
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/286b06ef66f7efdb8cdf48688678b429950d1b94558fe44fcd6cc6eb20c2100b/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:03:39

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 under 4 years of age 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma When using this product, do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a 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 (1-800-222-1222) right away.