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Nicadan

Medimetriks Pharmaceuticals, Inc.

NICADAN™


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx Only

Niacinamide, Vitamin B6, Vitamin C, Folic Acid,
Copper, Magnesium, Zinc & Alpha Lipoic Acid

NICADAN DESCRIPTION

Nicadan™ tablets are a specially formulated dietary supplement containing natural ingredients with anti-inflammatory properties. Each pink-coated tablet is oval shaped, scored and embossed with "MM". Nicadan™ is for oral administration only.

Nicadan™ should be administered under the supervision of a licensed medical practitioner.

INGREDIENTS

Each tablet of Nicadan™ contains:

Vitamin C (as Ascorbic Acid) 100 mg
Niacinamide (Vitamin B-3) 800 mg
Vitamin B-6 (as Pyridoxine HCI) 10 mg
Folic Acid 500 mcg
Magnesium (as Magnesium Citrate) 5 mg
Zinc (as Zinc Gluconate) 20 mg
Copper (as Copper Gluconate) 2 mg
Alpha Lipoic Acid 50 mg

Other Ingredients: Microcrystalline cellulose, Povidone, Hypromellose, Croscarmellose Sodium, Polydextrose, Talc, Magnesium Sterate Vegetable, Vegetable Stearine, Red Beet Powder, Titanium Dioxide, Maltodextrin and Triglycerides.

Nicadan™ is free of yeast, wheat, dairy, egg, soy, gluten, artificial color or flavors, added sugar, starch and preservatives.

USES

As a dietary supplement, Nicadan™ tablets are beneficial in maintaining overall skin health, especially in patients with inflammatory skin conditions. This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

WARNINGS

If you are pregnant, nursing or taking medication, consult your doctor before use.

NICADAN CONTRAINDICATIONS

Use of Nicadan™ is contraindicated in patients who are hypersensitive to any ingredient in this tablet.

PRECAUTIONS

There have been reports of GI upset, nausea, vomiting, heartburn, diarrhea, dizziness, drowsiness or headache with large doses of niacinamide. Rarely, niacinamide in doses of 3 grams/day or more has been associated with elevated liver function tests. There are case reports in the literature indicating that niacinamide may reduce the hepatic metabolism of primidone and carbamazepine. Individuals taking these medications should consult their physician. Individuals taking antidiabetes medications should have their blood glucose levels monitored.

Allergic sensitization has been reported rarely following oral administration of folic acid. Folic acid above 1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive.

NICADAN DOSAGE AND ADMINISTRATION

Take one tablet daily with food or as directled by a physician. Nicadan™ tablets are scored, so they may be broken in half if required.

HOW SUPPLIED

Nicadan™ is available in a bottle containing 60 tablets. 43538-440-60

Store at 15°C to 30°C (59°F to 86°F). Keep bottle tightly closed. Store in cool dry place.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

You may report side effects by calling 1-973-882-7512.

Manufactured for:

MEDIMETRIKS
PHARMACEUTICALS, INC.

383 Route 46 West, Fairfield, NJ 07004-2402 USA

www.medimetriks.com

Iss: 2/2014

IP038

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton

43538-440-60

Rx Only
NICADAN

Niacinamide, Vitamin B6, Vitamin C, Folic Acid,
Copper, Magnesium, Zinc & Alpha Lipoic Acid

Helps Maintain Overall
Skin Health

Dermatologist
Developed

60 Tablets

Dietary Supplement

MEDIMETRIKS
PHARMACEUTICALS, INC.

Nicadan

Nicadan

Ascorbic Acid, Niacinamide, pyridoxine hydrochloride, folic acid, magnesium citrate, zinc gluconate, copper gluconate, and .alpha.-lipoic acid TABLET, FILM COATED

Product Information

Product Type Dietary supplement Item Code (Source) NDC:43538-440
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ASCORBIC ACID ASCORBIC ACID 100 mg
NIACINAMIDE 800 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 10 mg
FOLIC ACID FOLIC ACID 500 ug
MAGNESIUM CITRATE MAGNESIUM CATION 5 mg
ZINC GLUCONATE zinc 20 mg
COPPER GLUCONATE 20 mg
.ALPHA.-LIPOIC ACID .ALPHA.-LIPOIC ACID 50 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
POVIDONES
HYPROMELLOSES
CROSCARMELLOSE SODIUM
POLYDEXTROSE
talc
titanium dioxide
maltodextrin

Product Characteristics

Color Size Imprint Code Shape
PINK 22 mm M;M OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:43538-440-60 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2014-02-22


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Be sure to consult your doctor before taking any medication!
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