FDA label 6f2a5c65-8fbf-4662-8908-3337c90ace5e

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
2ee839ee-e758-4bdb-9620-4e4c2b530da5
SPL ID
6f2a5c65-8fbf-4662-8908-3337c90ace5e
Version
2
Effective date
2012-01-05
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:11

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 As in the case of all medications, keep out of reach of children.

Adverse reactions cross-check#

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

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010.

Reported adverse events (FAERS/openFDA)#

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