FDA label b87590f2-ae9d-4fb9-843a-e2043edcb4f6

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
db8bff74-545a-42c6-816c-5327ba9c634c
SPL ID
b87590f2-ae9d-4fb9-843a-e2043edcb4f6
Version
103
Effective date
2023-03-03
Source export date
2026-09-28
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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:02:43

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 Ask your doctor before use if ▪ you have a persistent cough, this may be a sign of a serious condition ▪ you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ you have a cough that is accompanied by excessive phlegm (mucus) ▪ you have chronic pulmonary disease or shortness of breath ▪ giving to a child who is taking other drugs When using this product ▪ giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. ▪ may cause or aggravate constipation Stop use and ask a doctor if ▪ symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition. If pregnant or breast-feeding, ask a health professional before use. 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.