PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Label MARNEL NDC 0682-3001-01 BACMIN CAPLETS VITAMIN/MINERAL NUTRITIONAL SUPPLEMENT Rx ONLY 100 CAPLETS Manufactured for: MARNEL PHARMACEUTICALS, INC. Lafayette, Louisiana 70506
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in BACMIN. 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.
INDICATIONS & USAGE SECTION.
INDICATIONS BACMIN is indicated 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 of 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.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION Usual adult dosage: one caplet daily.
SPL UNCLASSIFIED SECTION.
Manufactured for: Marnel Pharmaceuticals, Lafayette, LA 70506 Manufactured by: Nexgen Pharma, Inc., Irvine, CA 92614 6381 Rev. 08/07B
HOW SUPPLIED SECTION.
HOW SUPPLIED Dark red caplets. Bottles of 30, NDC 0682-3001-30. Bottles of 100, NDC 0682-3001-01. Sample envelope - 2 caplets- NDC 0682-3001-02. Imprint MMD on top with plain lower.
DESCRIPTION BACMIN is a prescription-only oral multivitamin/mineral caplet specially formulated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. BACMIN supplies: therapeutic levels of water-soluble vitamins (ascorbic acid and all B-complex vitamins except biotin); supplemental levels of biotin, fat-soluble vitamins (A and E) and minerals (iron, chromium, manganese, copper, selenium and zinc); plus magnesium. Inactive ingredients: microcrystalline cellulose, silicon dioxide, stearic acid, croscarmellose sodium and magnesium stearate. Coating contains: hydroxypropyl methylcellulose, maltodextrin, hydroxypropyl cellulose, FD&C red No. 40 aluminum lake, triacetin, titanium dioxide, polyethylene glycol, FD&C blue No. 1 aluminum lake.
CONTRAINDICATIONS BACMIN is contraindicated in patients hypersensitive to any of its components.
WARNINGS 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, BACMIN is not recommended for patients undergoing such therapy.