FDA label 34917906-231c-4e2e-bf52-1035e8365b1f

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
a2656f9d-7f38-4c90-89d3-8788a93ab04d
SPL ID
34917906-231c-4e2e-bf52-1035e8365b1f
Version
3
Effective date
2022-08-18
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:05:19

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.