NDC | 0682-3001-01 |
Set ID | 34beae32-51e4-4bdc-8ca5-1d8d79f193b2 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Marnel Pharmaceuticals, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
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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 -
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.
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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.
- CONTRAINDICATIONS
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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.
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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
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Label
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INGREDIENTS AND APPEARANCE
BACMIN
vitamin a acetate, .alpha.-tocopherol acetate, ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, biotin, calcium pantothenate, folic acid, cyanocobalamin, flavone, ferrous fumarate, chromic chloride cr-51, magnesium oxide, manganese gluconate, cupric oxide, selenomethionine, and zinc oxide tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0682-3001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 2000 [iU] .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 30 [iU] ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 500 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 20 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 20 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 100 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 25 mg BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 150 ug CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 25 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 50 ug FLAVONE (UNII: S2V45N7G3B) (FLAVONE - UNII:S2V45N7G3B) FLAVONE 50 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 mg CHROMIC CHLORIDE CR-51 (UNII: U4M5Y13FGM) (CHROMIUM CR-51 - UNII:9QAU17N705) CHROMIC CHLORIDE CR-51 0.1 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 50 mg MANGANESE GLUCONATE (UNII: 9YY2F980SV) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE GLUCONATE 5 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 3 mg SELENOMETHIONINE (UNII: 964MRK2PEL) (SELENOMETHIONINE - UNII:964MRK2PEL) SELENOMETHIONINE 50 ug ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 22.5 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline (UNII: OP1R32D61U) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) croscarmellose sodium (UNII: M28OL1HH48) magnesium stearate (UNII: 70097M6I30) hypromelloses (UNII: 3NXW29V3WO) maltodextrin (UNII: 7CVR7L4A2D) hydroxypropyl cellulose (type h) (UNII: RFW2ET671P) FD&C red No. 40 (UNII: WZB9127XOA) aluminum oxide (UNII: LMI26O6933) triacetin (UNII: XHX3C3X673) titanium dioxide (UNII: 15FIX9V2JP) polyethylene glycols (UNII: 3WJQ0SDW1A) FD&C blue No. 1 (UNII: H3R47K3TBD) Product Characteristics Color RED (Dark Red) Score no score Shape OVAL Size 19mm Flavor Imprint Code MMD Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0682-3001-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/01/2000 Labeler - Marnel Pharmaceuticals, Inc. (053781795) Establishment Name Address ID/FEI Business Operations Nexgen Pharma, Inc. 160356114 MANUFACTURE(0682-3001)