FDA label 93640944-8e90-d456-e053-2995a90ac9fe

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
63fdf19e-f467-4873-8cbf-da2e5e2cdc0b
SPL ID
93640944-8e90-d456-e053-2995a90ac9fe
Version
4
Effective date
2019-09-25
Source export date
2026-08-08
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/ff6f8a7e8311a0dd3c947cd18ca343b8c43f8b6003d238bee8402e80a049f204/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 17:24:08

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 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 Ask a doctor or pharmacist before use if the child is taking sedatives 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 a sign of a serious condition. 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.