FDA label ed3733c1-5360-4397-9d41-d4d6984b8e44
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
- SPL set ID
- b781a162-244d-49b2-8918-031fce0587d7
- SPL ID
- ed3733c1-5360-4397-9d41-d4d6984b8e44
- Version
- 3
- Effective date
- 2021-01-01
- 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 01:29:25
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | ed3733c1-5360-4397-9d41-d4d6984b8e44 | id | |
| spl set id | b781a162-244d-49b2-8918-031fce0587d7 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • a breathing problem such as chronic bronchitis • cough that occurs with too much phlegm (mucus) • chronic cough that lasts such as occurs with asthma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product your child may • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if • child gets nervous, dizzy or sleepless • symptoms do not get better within 7 days or occur with fever • cough lasts 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. 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.