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 selenomet |
