Label: NICADAN- ascorbic acid, niacinamide, pyridoxine hydrochloride, folic acid, magnesium citrate, zinc gluconate, copper gluconate, and .alpha.-lipoic acid tablet, film coated
- NHRIC Code(s): 43538-440-60
- Packager: Medimetriks Pharmaceuticals, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated February 28, 2014
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- HEALTH CLAIM
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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.
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USES
As a dietary supplement, Nicadan™ tablets are beneficial in maintaining overall skin health, especially in patients with inflammatory skin conditions.1
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- 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
- CONTRAINDICATIONS
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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
- HOW SUPPLIED
- SAFE HANDLING WARNING
- PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
NICADAN
ascorbic acid, niacinamide, pyridoxine hydrochloride, folic acid, magnesium citrate, zinc gluconate, copper gluconate, and .alpha.-lipoic acid tablet, film coatedProduct 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)
