FDA label f4b11dda-ab34-42e5-9320-2f2a62539481

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
31ce0599-88e8-4829-bab0-21d22d43c80a
SPL ID
f4b11dda-ab34-42e5-9320-2f2a62539481
Version
5
Effective date
2012-02-01
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 06:21:53

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

What are the possible side effects of Novolin N? Low blood sugar (hypoglycemia). Symptoms of hypoglycemia (low blood sugar) may include: sweating trouble concentrating or confusion dizziness or lightheadedness blurred vision shakiness slurred speech hunger anxiety, irritability or mood changes fast heart beat headache tingling of lips and tongue Severe low blood sugar (hypoglycemia) can cause unconsciousness (passing out), seizures, and death. Know your symptoms of low blood sugar. Follow your healthcare provider’s instructions for treating low blood sugar. Talk to your healthcare provider if low blood sugar is a problem for you. Serious allergic reaction (whole body reaction). Get medical help right away if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating. Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions, or they are serious, talk to your healthcare provider. You may need to stop using Novolin N and use a different insulin. Do not inject insulin into skin that is red, swollen, or itchy. Skin thickens or pits at the injection site (lipodystrophy). Change (rotate) where you inject your insulin to help prevent these skin changes from happening. Do not inject insulin into this type of skin. Swelling of your hands and feet Vision changes Low potassium in your blood (hypokalemia) These are not all of the possible side effects from Novolin N. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

warnings table

<table width="0.000" ID="id_89395495-cace-46bb-91af-49181aafbbfa"> <col/> <col/> <tbody> <tr ID="id_3620250d-c1d0-4faa-95c1-62f0fab81500" styleCode="Toprule"> <td align="left" valign="top"> <list listType="unordered"> <item>sweating</item> </list> </td> <td align="left" valign="top"> <list listType="unordered"> <item>trouble concentrating or confusion</item> </list> </td> </tr> <tr ID="id_25961c5e-e75a-4d5f-bd56-b93b6448993c"> <td align="left" valign="top"> <list listType="unordered"> <item>dizziness or lightheadedness</item> </list> </td> <td align="left" valign="top"> <list listType="unordered"> <item>blurred vision</item> </list> </td> </tr> <tr ID="id_357dec86-5500-4254-b5e4-6120e9a80a69"> <td align="left" valign="top"> <list listType="unordered"> <item>shakiness</item> </list> </td> <td align="left" valign="top"> <list listType="unordered"> <item>slurred speech</item> </list> </td> </tr> <tr ID="id_b9f5ad8d-df2e-49ef-987c-ea9a9d9b0dda"> <td align="left" valign="top"> <list listType="unordered"> <item>hunger</item> </list> </td> <td align="left" valign="top"> <list listType="unordered"> <item>anxiety, irritability or mood changes</item> </list> </td> </tr> <tr ID="id_4266af6c-c314-4795-bab4-8363b57d47ec"> <td align="left" valign="top"> <list listType="unordered"> <item>fast heart beat</item> </list> </td> <td align="left" valign="top"> <list listType="unordered"> <item>headache</item> </list> </td> </tr> <tr ID="id_11a2cb33-9b5d-45d1-85b0-e66a2e00449b" styleCode="Botrule"> <td align="left" valign="top"> <list listType="unordered"> <item>tingling of lips and tongue</item> </list> </td> <td align="left" valign="top"/> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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