Megavite Rx

Generic Name: multivitamin, mineral
Dosage Form: tablet, film coated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Megavite Rx™
Caplets

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

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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.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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

Megavite Rx 
lemon, vitamin a acetate, ascorbic acid, alpha-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, chromic chloride, ferrous fumarate, magnesium oxide, zinc oxide, cupric oxide, manganese and selenomethionine se-75 tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-594
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lemon (Lemon) Lemon 50 mg
Vitamin A Acetate (Vitamin A) Vitamin A Acetate 2000 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 500 mg
ALPHA-TOCOPHEROL ACETATE, DL- (ALPHA-TOCOPHEROL ACETATE, DL-) ALPHA-TOCOPHEROL ACETATE, DL- 30 [iU]
Thiamine Mononitrate (Thiamine) Thiamine Mononitrate 20 mg
Riboflavin (Riboflavin) Riboflavin 20 mg
Niacinamide (Niacin) Niacin 100 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 50 ug
Biotin (Biotin) Biotin 150 ug
Calcium Pantothenate (Pantothenic Acid) Pantothenic Acid 25 mg
Chromic Chloride (Chromic Cation) Chromic Cation 0.1 mg
Ferrous Fumarate (Iron) Iron 27 mg
Magnesium Oxide (Magnesium Cation) Magnesium Oxide 50 mg
Zinc Oxide (Zinc) Zinc Oxide 22.5 mg
Cupric Oxide (Copper) Copper 3 mg
Manganese (Manganese) Manganese 5 mg
SELENOMETHIONINE SE-75 (Selenium) Selenium 50 ug
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene  
Citric Acid Monohydrate  
Croscarmellose Sodium  
Crospovidone  
Anhydrous Dibasic Calcium Phosphate  
FD&C Blue No. 1  
FD&C Red No. 40  
FD&C Yellow No. 6  
Aluminum Oxide  
Gelatin  
Hypromellose  
Magnesium Aluminum Silicate  
Magnesium Stearate  
Maltodextrin  
Cellulose, Microcrystalline  
Mineral Oil  
Polyethylene Glycol  
Povidone K30  
Silicon Dioxide  
Sodium Lauryl Sulfate  
Stearic Acid  
Sucrose  
Titanium Dioxide  
Product Characteristics
Color RED Score no score
Shape OVAL Size 20mm
Flavor Imprint Code B;594
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-594-01 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved other 06/01/2009
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Contract Pharmacal Corporation 057795122 MANUFACTURE
Revised: 10/2009
 
Breckenridge Pharmaceutical, Inc.
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