FDA Label for Bacmin
View Indications, Usage & Precautions
Bacmin Product Label
The following document was submitted to the FDA by the labeler of this product Marnel Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Vitamin/Mineral Nutritional Supplement
Rx ONLY
Manufactured for:
Marnel Pharmaceuticals,
Lafayette, LA 70506
Manufactured by:
Nexgen Pharma, Inc.,
Irvine, CA 92614
6381
Rev. 08/07B
Description
Each BACMIN caplet contains:
Quantity | |
---|---|
Fat-Soluble Vitamins | |
Vitamin A (vitamin A acetate) | 2000 IU |
Vitamin E (d-alpha tocopheryl acetate) | 30 IU |
Water-Soluble Vitamins | |
Vitamin C (ascorbic acid) | 500 mg |
Vitamin B1 (thiamine mononitrate) | 20 mg |
Vitamin B2 (riboflavin) | 20 mg |
Niacin (niacinamide) | 100 mg |
Vitamin B6 (pyridoxine HCl) | 25 mg |
Biotin | 150 mcg |
Pantothenic acid (D-calcium pantothenate) | 25 mg |
Folic acid | 1.0 mg |
Vitamin B12 (cyanocobalamin) | 50 mcg |
Lemon Bioflavonoids | 50 mg |
Minerals | |
Iron (ferrous fumarate) | 27 mg |
Chromium (chromium chloride) | 0.1 mg |
Magnesium (magnesium oxide) | 50 mg |
Manganese (manganese gluconate) | 5 mg |
Copper (cupric oxide) | 3 mg |
Selenium (L-selenomethionine) | 50 mcg |
Zinc (zinc oxide) | 22.5 mg |
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.
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.
- Recovery from surgery or trauma involving severe burns, fractures or other extensive tissue damage.
- Also, pregnant women and those with heavy menstrual bleeding.
Certain conditions resulting from severe B-Vitamin or ascorbic acid deficiency-
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.
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.
Dosage And Administration
Usual adult dosage: one caplet daily.
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.
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
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