FDA label a02a5ca8-8c0d-4be5-92b1-5271d555f252

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: 2cd6ab31-1fae-4737-b6af-50586323b751
SPL ID: a02a5ca8-8c0d-4be5-92b1-5271d555f252
Version: 4
Effective date: 2013-01-29
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:22:55

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		a02a5ca8-8c0d-4be5-92b1-5271d555f252	id
spl set id		2cd6ab31-1fae-4737-b6af-50586323b751	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 exceed recommended dosage. *Phenylketonurics: Contains Phenylalanine. When using this product Don’t take more than the recommended dosage. 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 a nd 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 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.