FDA.reportPublic FDA data

FDA label a09a162b-cfba-4c8d-91e0-e2de4ef53f31

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
dd702830-86df-4178-925e-9c6455a9af96
SPL ID
a09a162b-cfba-4c8d-91e0-e2de4ef53f31
Version
4
Effective date
2025-06-01
Source export date
2026-08-01
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/d245bd7ce31d1d8ed63276109973402ece6c44860774da30f25b731cd7418983/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:33:17

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules USP in combination with other prescribed drugs.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Potential Adverse Reactions to benzonatate capsules USP may include: Hypersensitivity reactions including bronchospasm, laryngospasm, and cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule. CNS: sedation; headache; dizziness; mental confusion; visual hallucinations. GI: constipation; nausea; GI upset. Dermatologic: pruritus; skin eruptions. Other: nasal congestion; sensation of burning in the eyes; vague "chilly" sensation; numbness of the chest; hypersensitivity. Rare instances of deliberate or accidental overdose have resulted in death.