FDA label fc109f3d-9f3f-4ee1-e053-6294a90a30ac

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: 250dac24-75a4-454c-9069-a9e52ab763f5
SPL ID: fc109f3d-9f3f-4ee1-e053-6294a90a30ac
Version: 8
Effective date: 2023-05-19
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:28:13

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		fc109f3d-9f3f-4ee1-e053-6294a90a30ac	id
spl set id		250dac24-75a4-454c-9069-a9e52ab763f5	set_id

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 take more than the recommended dosage. *Phenylketoneurics: Contains Phenylalanine. Ask a doctor before use if you have a Cough that occurs with too much phlegm (mucus). a Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema. Stop use and ask a doctor if Cough lasts more than seven days, returns or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, Do Not Use. Keep out of reach of children. In case of accidental 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.