FDA.reportPublic FDA data

FDA label 3c540ecc-eb30-43b7-bfac-2f43ee5d1544

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
9b85e2af-6103-4d0b-a5ea-517a0e604022
SPL ID
3c540ecc-eb30-43b7-bfac-2f43ee5d1544
Version
2
Effective date
2011-05-24
Source export date
2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:27

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: If pregnant or breast-feeding, do not take. Do not exceed recommended daily dosage. Not for use by or sale to persons under age 18. If you have a health condition or concern, it is recommended to do this program under the supervision of a health care provider. Stop use and ask a doctor if adverse reactions occur. Keep out of reach of children. In case of over dose, get medical help or contact a Poison Control Center right away. Do not use if seal is broken or missing. Store in a cool dark place.

Reported adverse events (FAERS/openFDA)#

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