FDA label 3c7fa1cf-93df-4f1d-be98-e7bed730da55

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
c04c66ed-d827-422c-bd80-008fd6ee4dac
SPL ID
3c7fa1cf-93df-4f1d-be98-e7bed730da55
Version
2
Effective date
2015-01-13
Source export date
2026-08-01
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/928e480b2a9ec5fd356ebc3e5dcca70f0f57b8a051cfbb174a4421de39bb77a2/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:26:05

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 May cause excitability, especially in children Do Not Use if you or your child are taking sedatives or tranquilizers, without first consulting your doctor if you or your child 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if your child has glaucoma a breathing problem such as emphysema or chronic bronchitis heart disease high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if: nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or are accompanied by a fever If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away.