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Bacmin

Generic Name: vitamin, mineral nutritional supplement
Dosage Form: tablet, coated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Bacmin

Vitamin/Mineral Nutritional Supplement
Rx ONLY

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 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.

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

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.

Bacmin Dosage and Administration

Usual adult dosage: one caplet daily.

How is Bacmin 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.

Manufactured for:
Marnel Pharmaceuticals,
Lafayette, LA 70506

Manufactured by:
Nexgen Pharma, Inc.,
Irvine, CA 92614

6381
Rev. 08/07B

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

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, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0682-3001
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 2000 [iU]
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL ACETATE 30 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 500 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 20 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 20 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 100 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 25 mg
BIOTIN (BIOTIN) BIOTIN 150 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 50 ug
FLAVONE (FLAVONE) FLAVONE 50 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
CHROMIC CHLORIDE CR-51 (CHROMIUM CR-51) CHROMIC CHLORIDE CR-51 0.1 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 50 mg
MANGANESE GLUCONATE (MANGANESE CATION (2+)) MANGANESE GLUCONATE 5 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 3 mg
SELENOMETHIONINE (SELENOMETHIONINE) SELENOMETHIONINE 50 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 22.5 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline  
silicon dioxide  
stearic acid  
croscarmellose sodium  
magnesium stearate  
hypromelloses  
maltodextrin  
hydroxypropyl cellulose (type h)  
FD&C red No. 40  
aluminum oxide  
triacetin  
titanium dioxide  
polyethylene glycols  
FD&C blue No. 1  
Product Characteristics
Color RED (Dark Red) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code MMD
Contains         
Packaging
# Item Code Package Description
1 NDC:0682-3001-01 100 TABLET, COATED 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 Operations
Nexgen Pharma, Inc. 160356114 MANUFACTURE(0682-3001)
Revised: 05/2014
 
Marnel Pharmaceuticals, Inc.
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