Nicotinamide

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)

Brand name
Nicotinamide
Generic name
NICOTINAMIDE
Manufacturer
Acella Pharmaceuticals, LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
05813526-41d0-4451-8543-f4288ba7eb95
SPL ID
e03ca6f2-c438-4b0a-9c19-db16e88697ac
Version
5
Effective date
2025-02-13
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 06:28:09
Harmonized routes table
Harmonized routes
ORAL

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

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. WARNINGS: If you are pregnant, nursing, or taking medication, consult your doctor before use. Use only under the advice and supervision of a physician if you have a history of jaundice, liver disease or diabetes. Abnormal liver function tests have been reported in persons taking daily doses of 500 mg or more of niacinamide. Folate intake should not exceed 250% of the Daily Value (1,000 mcg). PREGNANCY & NURSING MOTHERS: Nicotinamide Tablets is not indicated for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. Physicians and medical practitioners should administer Nicotinamide Tablets with caution to patients who are pregnant, lactating and/or taking medication. ADVERSE REACTIONS: Allergic sensitization has been reported rarely following oral and parental administration of Folate.

warnings table

<table width="638"><tbody><tr styleCode="First Last"><td styleCode="Botrule Lrule Rrule Toprule" align="left" valign="top"><content styleCode="bold">WARNINGS:</content> If you are pregnant, nursing, or taking medication, consult your doctor before use. Use only under the advice and supervision of a physician if you have a history of jaundice, liver disease or diabetes. Abnormal liver function tests have been reported in persons taking daily doses of 500 mg or more of niacinamide. Folate intake should not exceed 250% of the Daily Value (1,000 mcg).</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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