NICADAN- ascorbic acid, niacinamide, pyridoxine hydrochloride, folic acid, magnesium citrate, zinc gluconate, copper gluconate, and .alpha.-lipoic acid tablet, film coated

Nicadan by

Drug Labeling and Warnings

Nicadan by is a Other medication manufactured, distributed, or labeled by Medimetriks Pharmaceuticals, Inc., Contract Pharmacal. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

Rx Only

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

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.1

1 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.

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.

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.

SAFE HANDLING WARNING

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.

INGREDIENTS AND APPEARANCE

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)	NHRIC:43538-440
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	100 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	800 mg
pyridoxine hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z)	pyridoxine hydrochloride	10 mg
folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8)	folic acid	500 ug
magnesium citrate (UNII: RHO26O1T9V) (magnesium cation - UNII:T6V3LHY838)	magnesium citrate	5 mg
zinc gluconate (UNII: U6WSN5SQ1Z) (zinc cation - UNII:13S1S8SF37)	zinc gluconate	20 mg
copper gluconate (UNII: RV823G6G67) (cupric cation - UNII:8CBV67279L)	cupric cation	20 mg
.alpha.-lipoic acid (UNII: 73Y7P0K73Y) (.alpha.-lipoic acid - UNII:73Y7P0K73Y)	.alpha.-lipoic acid	50 mg

Inactive Ingredients
Ingredient Name	Strength
cellulose, microcrystalline (UNII: OP1R32D61U)
povidones (UNII: FZ989GH94E)
hypromelloses (UNII: 3NXW29V3WO)
croscarmellose sodium (UNII: M28OL1HH48)
polydextrose (UNII: VH2XOU12IE)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)
maltodextrin (UNII: 7CVR7L4A2D)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		02/22/2014

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	2
shape
size (solid drugs)	22 mm
imprint

Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal		968335112	MANUFACTURE(43538-440)