Nicotinamide - Acella Pharmaceuticals, LLC

Manufacturer
Acella Pharmaceuticals, LLC
Effective date
2026-07-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-10-14 00:02:14

Label at a glance#

ProductNicotinamide
Active ingredientNIACINAMIDE, ZINC GLYCINATE, LEVOMEFOLATE CALCIUM, CUPRIC OXIDE, SELENIUM, CHROMIUM
Label structure5 sections

Dosage and administration

Take 1-2 tablets daily, as a dietary supplement, as directed by your physician. Each white-colored, oval-shaped tablet is debossed with “342” on one side and blank on the other. OTHER INGREDIENTS: croscarmellose sodium, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, titanium dioxide, and triacetin.

Storage and handling

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature.] Do not use if seal under cap is broken or missing. 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. The listed product number is not a National Drug Code, but instead has merely been forma...

Label contents#

Full prescribing information#

DOSAGE AND ADMINISTRATION:

STATEMENT OF IDENTITY SECTION

Take 1-2 tablets daily, as a dietary supplement, as directed by your physician. Each white-colored, oval-shaped tablet is debossed with “342” on one side and blank on the other.

Nicotinamide SF Panel
Nicotinamide SF Panel

OTHER INGREDIENTS:croscarmellose sodium, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, titanium dioxide, and triacetin.

WARNINGS SECTION

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.Abnormal liver function tests have been reported in persons taking daily doses of 500 mg or more of niacinamide.

PRECAUTION: 

PRECAUTIONS SECTION

Folic acid alone is improper therapy and should not be used in treatment of pernicious anemia and other megaloblastic anemias where B 12is deficient. Folic acid should be used with care in the presence of peptic ulcer disease, regional enteritis, and ulcerative colitis. In doses above 0.1 mg daily, folic acid may obscure the diagnosis of pernicious anemia. Please consult with your healthcare provider to determine if this dose is appropriate for you and for any anemia related questions.

KEEP OUT OF THE REACH OF CHILDREN.

STORAGE AND HANDLING SECTION

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature.]

Do not use if seal under cap is broken or missing.

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.

The listed product number is not a National Drug Code, but instead has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

*Subject to one or more claims of U.S. Patent Nos. 7,582,418, 7,838,042 and 8,425,956.

Manufactured for:

Acella Pharmaceuticals, LLC

Alpharetta, GA 30005

1-800-541-4802

L-0468 Rev 0925-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotinamide BLNicotinamide BLNicotinamide BL 2Nicotinamide BL 2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42192-374-602025-02-13C16284748780-12cef2736-600c-d83d-e063-dadaa90ab31fNICOTINAMIDE
42192-374-602025-02-13C16284748780-12cef2736-600c-d83d-e063-dadaa90ab31fNICOTINAMIDE
42192-374-602025-01-30C16284748780-12cef2736-600c-d83d-e063-dadaa90ab31fNICOTINAMIDE
42192-374-602025-01-30C16284748780-12cef2736-600c-d83d-e063-dadaa90ab31fNICOTINAMIDE

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-374-60EA - Each42192-3743c999ad9-2a33-4444-9baa-1ac1fc7d877012021-06-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42192-37442192-374-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-02-13full-release2026-05-31 21:25:48

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotinamideNICOTINAMIDEAcella Pharmaceuticals, LLC05813526-41d0-4451-8543-f4288ba7eb952025-02-13WarningsExact identifier
ndc (package): 42192-374-60
ndc (product): 42192-374
ndc11 (package): 42192037460
spl set id: 05813526-41d0-4451-8543-f4288ba7eb95

Reported adverse events (FAERS/openFDA)#

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