Wednesday, October 12, 2016

Megavite Rx



multivitamin, mineral

Dosage Form: tablet, film coated
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


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 TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)51991-594
Route of AdministrationORALDEA Schedule    






























































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lemon (Lemon)Lemon50 mg
Vitamin A Acetate (Vitamin A)Vitamin A Acetate2000 [iU]
Ascorbic Acid (Ascorbic Acid)Ascorbic Acid500 mg
ALPHA-TOCOPHEROL ACETATE, DL- (ALPHA-TOCOPHEROL ACETATE, DL-)ALPHA-TOCOPHEROL ACETATE, DL-30 [iU]
Thiamine Mononitrate (Thiamine)Thiamine Mononitrate20 mg
Riboflavin (Riboflavin)Riboflavin20 mg
Niacinamide (Niacin)Niacin100 mg
Pyridoxine Hydrochloride (Pyridoxine)Pyridoxine Hydrochloride25 mg
Folic Acid (Folic Acid)Folic Acid1 mg
Cyanocobalamin (Cyanocobalamin)Cyanocobalamin50 ug
Biotin (Biotin)Biotin150 ug
Calcium Pantothenate (Pantothenic Acid)Pantothenic Acid25 mg
Chromic Chloride (Chromic Cation)Chromic Cation0.1 mg
Ferrous Fumarate (Iron)Iron27 mg
Magnesium Oxide (Magnesium Cation)Magnesium Oxide50 mg
Zinc Oxide (Zinc)Zinc Oxide22.5 mg
Cupric Oxide (Copper)Copper3 mg
Manganese (Manganese)Manganese5 mg
SELENOMETHIONINE SE-75 (Selenium)Selenium50 ug


















































Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeOVALSize20mm
FlavorImprint CodeB;594
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
151991-594-01100 TABLET In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved other06/01/2009


Labeler - Breckenridge Pharmaceutical, Inc. (150554335)









Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corporation057795122MANUFACTURE
Revised: 10/2009Breckenridge Pharmaceutical, Inc.

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