SLO-NIACIN 500 mg

Basic Information

Product Label

Product label for SLO-NIACIN 500 mg
Full Name: SLO-NIACIN 500 mg
Brand: Upsher-Smith none
Product Type: Vitamin
Physical State: Tablet or Pill
UPC/SKU: 3 0245-0063-11 7
Product Version Code: 107699-02 R0513

Contact Information

Manufactured by

Name: Upsher-Smith Laboratories, Inc.
Address:6701 Evenstad Drive, Maple Grove, MN, 55369
Phone: 1-800-654-2299
Website: www.slo-niacin.com
Types: Manufacturer

Product Details

Net Contents

100 Tablet(s)(100 Tablet(s))

Serving Sizes

Unit:Tablet(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Adult (18 - 50 Years)

Ingredients & Nutrition

Group: Glyceryl behenate

HPMC

other

Group: Hypromellose

Also known as: Hydroxypropylmethylcellulose, Hydroxypropyl Methyl Cellulose, Hydroxypropyl Methylcellulose, Hypromellose

Group: Hydrogenated Vegetable Oil

Niacin

vitamin

Group: Niacin

Also known as: Vitamin B3, Vit. B-3, B3, Niacinol, Nicotinic Acid, B-3, Vitamin B-3

UNII Code: 2679MF687A

Group: Color

Red 40, also known as Allura Red AC, is a synthetic azo dye derived from petroleum used extensively as a red food colorant. It is approved by the FDA for use in foods, beverages, cosmetics, and pharmaceuticals. It imparts a bright red hue and is commonly found in candies, soft drinks, baked goods, and other processed products.

Also known as: Allura Red AC, FD&C Red No. 40, E129, Red Dye #40, Allura Red

UNII Code: 2Z6R9D8D4B

Group: Silicon

Also known as: SiO2

UNII Code: ETJ7Z6XBU4

Product Statements

General Statements: All Other Content

Unique polygel system designed to minimize flushing

FDA Statement of Identity

Dietary Supplement

Formula re: Contains

Slo-Niacin 500 mg

General Statements: All Other Content

Clinically proven to support good cholesterol (HDL)

Seals/Symbols

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

Formula re: Contains

Contains a doctor-recommended form of niacin

General Statements: All Other Content

Controlled release to reduce flushing

Brand IP Statement(s) re: (c), (TM), (SM)

Description Slo-Niacin tablets are manufactured utilizing a unique, polygel controlled-release delivery system.

General Statements: All Other Content

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.

Brand IP Statement(s) re: (c), (TM), (SM)

Slo-Niacin tablets are available in 250 mg, 500 mg, and 750 mg strengths.

Suggested/Recommended/Usage/Directions

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.

Storage

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

General: Product/Version Code

107699-02 R0513

Precautions re: All Other

Caution Niacin 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.

Precautions re: Allergies

Warnings Slo-Niacin tablets should not be used by persons with a known sensitivity or allergy to niacin.

Precautions re: All Other

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).

Precautions re: Pregnant or Nursing or Prescription Medications

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.

Precautions re: All Other

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.

Precautions re: All Other

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.

Precautions re: Children

Keep out of reach of children.

Brand IP Statement(s) re: (c), (TM), (SM)

2013 Upsher-Smith Laboratories, Inc.

FDA Disclaimer Statement

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.

Brand IP Statement(s) re: (c), (TM), (SM)

Slo-Niacin tablets support a healthy heart

General Statements: All Other Content

Helps maintain good cholesterol (HDL) within the normal range

Formula re: Contains

Contains a doctor recommended form or niacin-nicotinic acid

General Statements: All Other Content

Unique polygel system designed to minimize flushing

General Statements: All Other Content

1. Data on file. Upsher-Smith Laboratories, Inc. 2. Slo-Niacin (product information). Minneapolis, MN: Upsher-Smith Laboratories, Inc; 2011.

General Statements: All Other Content

105186-03 08

Brand IP Statement(s) re: (c), (TM), (SM)

Slo-Niacin Tablets

General Statements: All Other Content

250, 500, and 750 mg

Suggested/Recommended/Usage/Directions

Suggested Use Slo-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.

Suggested/Recommended/Usage/Directions

Directions 250 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.

Precautions re: All Other

Before using 500 mg daily or more, consult a physician.

Suggested/Recommended/Usage/Directions

Note: Slo-Niacin tablets may be broken on the score line, but should not be crushed or chewed.

General Statements: All Other Content

Ingredients 250 mg niacin (nicotinic acid), supplying 1,250% of the Daily Value (DV) for niacin.

Formula re: Contains

500 mg niacin (nicotinic acid), supplying 2,500% of the Daily Value (DV) for niacin.

General Statements: All Other Content

750 mg niacin (nicotinic acid), supplying 3,750% of the Daily Value (DV) for niacin.

Formula re: Contains

Each tablet also contains: hypromellose, hydrogenated vegetable oil, silicon dioxide, magnesium stearate, glyceryl behenate, Red 40.

Brand IP Statement(s) re: (c), (TM), (SM)

2014 Upsher-Smith Laboratories, Inc.

General Statements: All Other Content

105186-03 Revised 0614

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