Megavite Rx

Megavite Rx Description

Each Megavite Rx™ Caplet Contains

Fat-Soluble Vitamins

Vitamin A (as Vitamin A Acetate) ........................................... 2000 IU
Vitamin E (as dl-Alpha Tocopheryl Acetate) ............................... 30 IU

Water-Soluble Vitamins

Vitamin C (Ascorbic Acid) ....................................................... 500 mg
Vitamin B1 (as Thiamine Mononitrate) ........................................ 20 mg
Vitamin B2 (Riboflavin) ............................................................... 20 mg
Niacin (Niacinamide)................................................................. 100 mg
Vitamin B6 (as Pyridoxine HCl) .................................................. 25 mg
Biotin ..................................................................................... 150 mcg
Pantothenic Acid (as D-Calcium Pantothenate)............................ 25 mg
Folic Acid.................................................................................. 1.0 mg
Vitamin B12 (Cyanocobalamin) ................................................. 50 mcg
Lemon Bioflavonoids................................................................... 50 mg

Minerals

Iron (as Ferrous Fumarate) ......................................................... 27 mg
Chromium (as Chromium Chloride)............................................. 0.1 mg
Magnesium (as Magnesium Oxide) .............................................. 50 mg
Manganese (as Manganese Gluconate)........................................... 5 mg
Copper (as Cupric Oxide) ............................................................ 3 mg
Selenium (as L-Selenomethionine) ............................................. 50 mcg
Zinc (as Zinc Oxide) ................................................................ 22.5 mg

Inactive Ingredients: BHT, Citric Acid, Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, FD&C Blue No.1 Lake, FD&C Red No.40 Lake, 1FD&C Yellow No.6 Lake, Gelatin, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Soy Polysaccharide, Starch, Stearic Acid, Sucrose and Titanium Dioxide.

Allergen: Contains Soy

1

Contains FD&C Yellow No.6 Lake as a color additive

INDICATIONS

Megavite Rx™ is a prescription - only oral multivitamin/mineral caplet specially formulated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include:

Conditions causing depletion, reduced absorption or bioavailability of essential vitamins and minerals-

• Inadequate intake due to highly restricted or unbalanced diets such as those frequently associated with anorexic conditions and other states severe malnutrition.
• Gastrointestinal disorders, chronic alcoholism, chronic or acute infections (especially those involving febrile illness), prolonged or wasting disease, congestive heart failure, hyperthyroidism, poorly controlled diabetes or other physiologic stress.
• Also, patients on estrogenic oral contraceptives or other estrogen therapy, anti-bacterials which affect intestinal microflora, or other interfering drugs.

Certain conditions resulting from severe B- Vitamin or ascorbic acid deficiency-

• Recovery from surgery or trauma involving severe burns, fractures or other extensive tissue damage.
• Also, pregnant women and those with heavy menstrual bleeding.

Contraindications

Megavite Rx™ is contraindicated in patients hypersensitive to any of the ingredients.

Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

Not intended for treatment of pernicious anemia or other megaloblastic anemias where vitamin B12 is deficient. Neurological involvement may develop or progress, despite temporary remission of anemia, in patients with vitamin B12 deficiency who receive supplemental folic acid and who are inadequately treated with B12 .

Drug and Treatment Interactions

As little as 5 mg pyridoxine daily can decrease the efficiency of levodopa in the treatment of parkinsonism. Therefore, Megavite Rx™ is not recommended for patients undergoing such therapy.

Precautions

General

Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Adverse Reactions

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Megavite Rx™. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Megavite Rx Dosage and Administration

Usual adult dosage: one caplet daily. Not recommended for children.

How is Megavite Rx Supplied

Megavite Rx™ is available as a film-coated red caplet. They are debossed B 594 in bottles of 100 caplets. NDC 51991-594-01.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Protect from light and moisture.

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788 USA

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Rx Only

Iss. 12/08

PRINCIPAL DISPLAY PANEL - 100 Caplets Label

Breckenridge
Pharmaceutical, Inc.

NDC 51991-594-01

Megavite Rx™
Caplets

Rx Only

100 CAPLETS