SLO-NIACIN 500 mg

Product Overview

Brand: Upsher-Smith

Barcode: 3 0245-0063-11 7

Net Contents: 100 Tablet(s)

Serving Size (Overview): 1 Tablet(s)

Product Type: Vitamin [A1302]

Form: Tablet or Pill [E0155]

Date Entered: May 24, 2017

Market Status: On Market

Suggested Use (Overview): Directions: Adults - one Slo-Niacin tablet morning or evening; or as directed by a physician. Before using 500 mg daily or more; consult a physician. Note: Slo-Niacin tablets may be broken on the score line; but should not be crushed or chewed. Suggested UseSlo-Niacin is a member of the vitamin B-complex group (nicotinic acid; vitamin B3) and is suggested as a dietary supplement. This product has the advantage of a slower release of niacin than conventional dosage forms. This may permit its use by those who do not tolerate immediate-release tablets. Directions250 mg: Adults — one Slo-Niacin Tablet morning or evening; or as directed by a physician.500 mg: Adults — one Slo-Niacin Tablet morning or evening; or as directed by a physician.750 mg: Adults — one Slo-Niacin Tablet morning or evening; or as directed by a physician. Note: Slo-Niacin tablets may be broken on the score line; but should not be crushed or chewed.

Product Self-Roles:

No specific self-roles defined.

Dietary Supplement Facts

Ingredient	Category	Amount Per Serving	Unit	% Daily Value	Target Group	Serving Size (Fact)
Niacin	vitamin	500	mg	2500	Adults and children 4 or more years of age	1 Tablet(s)

Other Ingredients

Hypromellose; Hydrogenated Vegetable Oil; Silicon Dioxide (SiO2); Magnesium Stearate; Glyceryl Behenate; Red 40

Label Statements

Other

Unique polygel system designed to minimize flushing Clinically proven to support good cholesterol (HDL) Controlled release to reduce flushing This exclusive technology ensures the gradual and measured release of niacin (nicotinic acid a form of vitamin B3) and is designed to reduce the incidence of flushing and itching commonly associated with niacin use. Helps maintain good cholesterol (HDL) within the normal range Unique polygel system designed to minimize flushing 1. Data on file. Upsher-Smith Laboratories Inc.2. Slo-Niacin (product information). Minneapolis MN: Upsher-Smith Laboratories Inc; 2011. 105186-03 08 250 500 and 750 mg Ingredients 250 mg niacin (nicotinic acid) supplying 1250% of the Daily Value (DV) for niacin. 750 mg niacin (nicotinic acid) supplying 3750% of the Daily Value (DV) for niacin. 105186-03 Revised 0614

Statement of Identity

Dietary Supplement This statements has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose treat cure or prevent any disease.

Formulation

Slo-Niacin 500 mg Contains a doctor-recommended form of niacin Contains a doctor recommended form or niacin-nicotinic acid 500 mg niacin (nicotinic acid) supplying 2500% of the Daily Value (DV) for niacin. Each tablet also contains: hypromellose hydrogenated vegetable oil silicon dioxidemagnesium stearate glyceryl behenate Red 40.

Seals/Symbols

#1 Pharmacist Recommended 2013-2014 U.S.News & World Report Pharmacy Times

Branding Statement(s)

DescriptionSlo-Niacin tablets are manufactured utilizing a unique polygel controlled-release delivery system. Slo-Niacin tablets are available in 250 mg 500 mg and 750 mg strengths. 2013 Upsher-Smith Laboratories Inc. Slo-Niacin tablets support a healthy heart Slo-Niacin Tablets 2014 Upsher-Smith Laboratories Inc.

Suggested Use

Directions: Adults; one Slo-Niacin tablet morning or evening or as directed by a physician. Before using 500 mg daily or more consult a physician. Note: Slo-Niacin tablets may be broken on the score line but should not be crushed or chewed. Suggested UseSlo-Niacin is a member of the vitamin B-complex group (nicotinic acid vitamin B3) and is suggested as a dietary supplement. This product has the advantage of a slower release of niacin than conventional dosage forms. This may permit its use by those who do not tolerate immediate-release tablets. Directions250 mg: Adults — one Slo-Niacin Tablet morning or evening or as directed by a physician.500 mg: Adults — one Slo-Niacin Tablet morning or evening or as directed by a physician.750 mg: Adults — one Slo-Niacin Tablet morning or evening or as directed by a physician. Note: Slo-Niacin tablets may be broken on the score line but should not be crushed or chewed.

Product Specific Information

Store at controlled room temperature 15-30(0)C (59-86(0)F). Keep tightly closed.

Product/Version Code

107699-02 R0513

Precautions

CautionNiacin may cause temporary flushing itching and tingling feelings of warmth and headache particularly when beginning increasing the amount or changing brand of niacin. These effects seldom require discontinuing niacin use. Skin rash upset stomach and low blood pressure when standing are less common symptoms if they persist contact a physician. WarningsSlo-Niacin tablets should not be used by persons with a known sensitivity or allergy to niacin. Persons with heart disease particularly those who have recurrent chest pain (angina) or who recently suffered a heart attack should take niacin only under the supervision of a physician. Persons taking high blood pressure or cholesterol-lowering drugs should contact a physician before taking niacin because of possible interactions. Case reports of myopathy (unexplained muscle related complaints including discomfort weakness or tenderness) have been documented with the use of HMG-CoA Reductase Inhibitors in combination with lipid-altering doses of niacin therapy (=1 gram of niacin per day). Do not take niacin unless recommended by and taken under the supervision of a physician if you have any of the following conditions: gallbladder disease gout arterial bleeding glaucoma diabetes impaired liver function peptic ulcer pregnancy or lactating women. Increased uric acid and glucose levels and abnormal liver function tests have been reported in persons taking daily doses of 500 mg or more of niacin. Discontinue use and consult a physician immediately if any of the following symptoms occur: persistent flu-like symptoms (nausea vomiting a general “not well” feeling); loss of appetite; a decrease in urine output associated with dark-colored urine; muscle discomfort such as tender swollen muscles or muscle weakness; irregular heartbeat; or cloudy or blurry vision. Keep out of reach of children. Before using 500 mg daily or more consult a physician.