FDA label 074eae14-638f-49df-9574-8936813a2d00

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
fd6dac8a-e66a-63bd-6c26-23f7dfe00215
SPL ID
074eae14-638f-49df-9574-8936813a2d00
Version
2
Effective date
2019-12-30
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:23:32

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: Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing swelling of tongue trouble speaking wheezing or problems breathing dizziness or loss of conciousness swelling in or around mouth drooling These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Reported adverse events (FAERS/openFDA)#

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