FDA label 328103e7-33de-464b-bff9-763018f8cf19

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: c9b4d562-9c3a-4dfd-bea1-23bec67c2992
SPL ID: 328103e7-33de-464b-bff9-763018f8cf19
Version: 4
Effective date: 2021-12-20
Source export date: 2026-11-06
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:51:43

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		328103e7-33de-464b-bff9-763018f8cf19	id
spl set id		c9b4d562-9c3a-4dfd-bea1-23bec67c2992	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 use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have been diagnosed with a condition known to weaken immunity such as HIV, the virus that causes AIDS. Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur. Keep out of reach of children . In case of overdose, get medical help of call a Poison Control Center right away. If pregnant or breast feeding , ask a health professional before using product. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken. Store at room temperature.

Reported adverse events (FAERS/openFDA)#

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