FDA.reportPublic FDA data

FDA label 78d81a83-fcd1-2753-e053-2a91aa0a23bc

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
d9ec5382-0091-44e2-b322-7542b5386561
SPL ID
78d81a83-fcd1-2753-e053-2a91aa0a23bc
Version
2
Effective date
2018-10-22
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 02:48:50

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 a doctor before use if you have ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ■ cough accompanied by excessive phlegm (mucus) When using this product ■ do not exceed recommended dosage ■ do not use for more than 7 days Stop use and ask a doctor if ■ cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding ask a health professional before use

Reported adverse events (FAERS/openFDA)#

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