FDA label f21ebdf8-5dc4-44bd-9889-3f71ad6c8f8a

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
d9a7c7eb-22e1-4361-a708-99f4ed5c3a2c
SPL ID
f21ebdf8-5dc4-44bd-9889-3f71ad6c8f8a
Version
2
Effective date
2024-10-01
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:24:27

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.