FDA label aa1e24f0-764a-4404-b07c-77c0d60f4361

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
ea65a333-c796-4481-b24d-91daceb9c947
SPL ID
aa1e24f0-764a-4404-b07c-77c0d60f4361
Version
3
Effective date
2019-02-13
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:23

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 an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if child has 1. a breathing problem such as chronic bronchitis 2. cough that occurs with too much phlegm (mucus) 3. chronic cough that lasts such as occurs with asthma 4. heart disease 5. thyroid disease 6. glaucoma 7. diabetes 8. high blood pressure Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product 1. do not use more than directed 2. drowsiness may occur 3. excitability may occur, especially in children 4. sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if 1. cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. 2. the child gets nervous, dizzy or sleepless 3. symptoms do not get better within 7 days or occur with fever 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.