FDA label b68effd5-0f46-4480-8ba6-e292992f4431

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
2853efbc-9ce3-4254-b24f-28b5bd80105b
SPL ID
b68effd5-0f46-4480-8ba6-e292992f4431
Version
2
Effective date
2011-08-24
Source export date
2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:12:34

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 exceed recommended dosage. Do not use this product •under 4 years of age •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 the child has •a breathing problem such as chronic bronchitis •glaucoma •a persistent or chronic cough such that occurs with asthma •a cough that occurs with too much phlegm (mucus) •heart disease •high blood pressure •thyroid disease •diabetes mellitus Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product •excitability may occur, especially in children •may cause marked drowsiness •sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if •nervousness, dizziness, or sleeplessness occur •cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. •new symptoms occur Keep out of the 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.