FDA label ad7f541a-77bf-4739-aa19-d592c0e4b241
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
- e25686be-d652-4ac5-8d52-4d9de03eec3b
- SPL ID
- ad7f541a-77bf-4739-aa19-d592c0e4b241
- Version
- 2
- Effective date
- 2017-07-28
- Source export date
- 2026-10-12
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:30:04
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 | ad7f541a-77bf-4739-aa19-d592c0e4b241 | id | |
| spl set id | e25686be-d652-4ac5-8d52-4d9de03eec3b | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS This product contains iron. Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Extreme caution should be used when prescribing this product to patients with a history of liver disease, jaundice, diabetes and/or kidney disease. These patients, as well as patients with a history of heavy use of alcohol, gallbladder disease, gout, and/or stomach ulcers, should be monitored closely. Abnormal liver functions tests have been reported in persons taking high doses of niacin. Patients with coronary artery disease or unstable angina should not take niacin without their licensed medical practitioner's supervision, as large doses can increase the risk of heart rhythm problems. Caution is also advised in patients with low blood pressure as niacin may cause a dangerous drop in blood pressure. Niacin can be toxic to the liver at high doses. Do not exceed 3 grams per day of nicotinamide. 1 Do not use other niacin-containing products while taking this product unless under the supervision of a licensed healthcare practitioner. This product is not formulated or intended to be used to treat hyperlipidemias. This product contains four different forms of niacin as Quadracin™, with the majority of the niacin being supplied in slowly metabolized forms, such as nicotinamide and inositol nicotinate. Nicotinamide does not have the same lipid modifying effects as nicotinic acid. Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group. Patients undergoing cancer treatment should consult their licensed medical practitioner for advice. Before having surgery, tell your licensed medical practitioner that you are taking this product.
Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS "Niacin flush" is a burning, tingling sensation in the face and chest, and red or flushed skin and is associated with rapidly metabolized niacin DermaNIC™ is formulated primarily with slowly metabolized niacin vitamers that present a lower risk of flushing than rapidly metabolized forms. Nevertheless, some patients may want to titrate slowly to the maintenance level as prescribed by a licensed medical practitioner. . This reaction usually goes away as the body gets used to the medication. Other side effects of niacin include stomach upset, intestinal gas, dizziness, and pain in the mouth. Allergic reactions have been reported following the use of oral and parenteral folate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. Call your medical practitioner about side effects. You may report side effects by calling 1-866-633-9033.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.