FDA label 75f38097-374b-4ed2-b8ce-c1448c2e96fe

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
6efe00ca-087c-44ae-843a-7db8999de066
SPL ID
75f38097-374b-4ed2-b8ce-c1448c2e96fe
Version
3
Effective date
2024-11-19
Source export date
2026-10-12
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/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:37:35

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 on MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if child has • diabetes • glaucoma • thyroid disease • heart disease • high blood pressure • cough that occurs with too much phlegm (mucus) • a breathing problem such as chronic bronchitis • chronic cough that lasts such as occurs with asthma or tranquilizers When using this product • do not use more than directed • excitability may occur, especially in children • drowsiness may occur • sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if • the child gets nervous, dizzy or sleepless • cough lasts more than 7 days, comes back or occurs with fever, rash or persistent headache. A persistent cough may be sign of a serious condition. • Symptoms do not get better within 7 days or occur with fever

Reported adverse events (FAERS/openFDA)#

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