FDA label 5d452c9a-71ba-43ed-9b45-22c752c6e106

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
278e3582-335f-4771-b0bc-abba292c9c6b
SPL ID
5d452c9a-71ba-43ed-9b45-22c752c6e106
Version
3
Effective date
2023-07-12
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:04

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 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. Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

warnings

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.