FDA label b7ef6a31-aebf-4af2-8b1e-9bd1538d9875

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: d9b633b8-7f26-479c-8d74-d353241c1506
SPL ID: b7ef6a31-aebf-4af2-8b1e-9bd1538d9875
Version: 2
Effective date: 2019-01-15
Source export date: 2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:49:45

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		b7ef6a31-aebf-4af2-8b1e-9bd1538d9875	id
spl set id		d9b633b8-7f26-479c-8d74-d353241c1506	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 is symptoms persist, worsen or if new symptoms occur. Keep out of reach of children. In case of overdose, get medical help or 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. OTHER INFORMATION: Store at room temperature.

Reported adverse events (FAERS/openFDA)#

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