FDA label 43d3f785-fa39-929d-e063-6294a90ab035

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
2e91a3de-e8ff-5d65-e054-00144ff8d46c
SPL ID
43d3f785-fa39-929d-e063-6294a90ab035
Version
5
Effective date
2025-11-17
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:37:55

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

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN. • This product is intended to complement not replace standard medical treatments.•Initial worsening of symptoms may occur. •If you are pregnant or breast-feeding, ask a health care professional before use • Keep out of reach of children under the age of 12. Stop use and ask a doctor if: Stop use and ask a doctor if: • New symptoms such as cough, congestion, allergies, and/or mouth, teeth or jaw problems occur. • In case of overdose get medical help or contact a poison control center right away.

Reported adverse events (FAERS/openFDA)#

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