FDA label a7afbe7b-c702-b8d7-e053-2a95a90a15b2

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
5d90a57d-be06-945c-e053-2a91aa0a9ad9
SPL ID
a7afbe7b-c702-b8d7-e053-2a95a90a15b2
Version
3
Effective date
2020-06-09
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:01:41

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warings Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

warnings

WARNINGS: Do not use if Taper Evident Seal is broken or missing. This product is sealed with either a shrink band around cap imprinted "Sealed For your Protection" or foil seal under cap.

Reported adverse events (FAERS/openFDA)#

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