FDA label 7b69e722-3d06-4fda-ab01-fce6d4755509

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
7b09c184-83ae-4bfc-ad9b-3c216ca443c7
SPL ID
7b69e722-3d06-4fda-ab01-fce6d4755509
Version
9
Effective date
2021-06-14
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:47:58

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: Do not use this product if you are pregnant, attempting to become pregnant, or breast-feeding. Do not take this product for persistent or chronic cough such that occurs with smoking, asthma, chronic bronchitis or emphysema or where cough is accompaied by excessive phlegm (mucus) unless directed by a doctor. Ask a doctor before use if you have: Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema have a cough that is accompanied by excessive phlegm (mucus). have diabetes are taking antibiotics or any other prescription drug. Stop use and ask a doctor if cough persists more than one week, tends to recur, or is accompanied by a fever, rash or persisient headache. A persistent cough may be a sign of a serious condition. If you are taking any medications, consult a healthcare professional before use. Keep out of reach of children. In case of overdoese seek medical help or contact a Posion Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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