FDA label 95bdcbbd-18a8-4f20-8b27-7ec467b79329

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
d5a0595d-1f29-485d-afe0-452b0d5a3a8d
SPL ID
95bdcbbd-18a8-4f20-8b27-7ec467b79329
Version
1
Effective date
2011-01-19
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:37:13

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Before prescribing medication to suppress or modify a cough, it is important that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

6 ADVERSE REACTIONS Signs of potential side effects that require medical attention only if persistant include, but are not limited to: mild dizziness, mild drowsiness, nausea or vomiting, stomach pain. Those indicating immediate medical attention include confusion, drowsiness or dizziness (severe), nausea or vomiting (severe), unusual excitement, nervousness, restlessness, or irritability (severe).

Reported adverse events (FAERS/openFDA)#

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