FDA label 53cad8ea-ed6a-4476-9979-3450dc580bb9
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
- SPL set ID
- 99c5f7b5-8225-4ce0-bc21-57b2f8f19ffb
- SPL ID
- 53cad8ea-ed6a-4476-9979-3450dc580bb9
- Version
- 6
- Effective date
- 2012-02-01
- Source export date
- 2026-10-12
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:33:42
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 53cad8ea-ed6a-4476-9979-3450dc580bb9 | id | |
| spl set id | 99c5f7b5-8225-4ce0-bc21-57b2f8f19ffb | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 70/30 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 70/30. 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. How should I store Novolin 70/30? All Unopened Novolin 70/30: Keep all unopened Novolin 70/30 in the refrigerator between 36 ° to 46 ° F (2 ° to 8 ° C). Do not freeze. Do not use Novolin 70/30 if it has been frozen. If refrigeration is not possible, the unopened vial may be kept at room temperature for up to 6 weeks (42 days), as long as it is kept at or below 77°F (25°C). Keep unopened Novolin 70/30 in the carton to protect from light. Novolin 70/30 in use: Vials Keep at room temperature below 77°F (25°C) for up to 6 weeks (42 days). Keep vials away from direct heat or light. Throw away an opened vial after 6 weeks (42 days) of use, even if there is insulin left in the vial. Unopened vials can be used until the expiration date on the Novolin 70/30 label, if the medicine has been stored in a refrigerator. General advice about Novolin 70/30 Novolin 70/30 is used for the treatment of diabetes only. Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use Novolin 70/30 for a condition for which it was not prescribed. Do not give Novolin 70/30 to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about Novolin 70/30. If you would like more information about Novolin 70/30 or diabetes, talk with your healthcare provider. For more information, call 1-800-727-6500 or visit www.novonordisk-us.com. Helpful information for people with diabetes is published by the American Diabetes Association, 1701 N Beauregard Street, Alexandria, VA 22311 and on www.diabetes.org.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
What are the possible side effects of Novolin 70/30? 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
adverse reactions table
<table width="0.000" ID="id_81d7eb2f-8605-4bf5-a3d6-c177983ee649"> <col/> <col/> <tbody> <tr ID="id_0644ac87-c2bb-459d-b94b-8da1fc837a06" 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_fc06b0d4-7335-4ba6-839f-5d67df1238ba"> <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_3b23af63-d9cf-44bb-aed0-6d81fb66293e"> <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_d2b6857a-e0c1-4b9b-8d2e-268f40264f20"> <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_cdf270d6-89d3-4a37-8e83-a60905cb349a"> <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_753221b2-d09b-431e-9f74-2e3850ff8606" 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.