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 
Marnel Pharmaceuticals, Inc.

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.

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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
Biotin150 mcg
Pantothenic acid (D-calcium pantothenate)25 mg
Folic acid1.0 mg
Vitamin B12 (cyanocobalamin)50 mcg
Lemon Bioflavonoids50 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.

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-

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.

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

PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Label
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0682-3001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2000 [iU]
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE30 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID500 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE20 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN20 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE100 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN150 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN50 ug
FLAVONE (UNII: S2V45N7G3B) (FLAVONE - UNII:S2V45N7G3B) FLAVONE50 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
CHROMIC CHLORIDE CR-51 (UNII: U4M5Y13FGM) (CHROMIUM CR-51 - UNII:9QAU17N705) CHROMIC CHLORIDE CR-510.1 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE50 mg
MANGANESE GLUCONATE (UNII: 9YY2F980SV) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE GLUCONATE5 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION3 mg
SELENOMETHIONINE (UNII: 964MRK2PEL) (SELENOMETHIONINE - UNII:964MRK2PEL) SELENOMETHIONINE50 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorRED (Dark Red) Scoreno score
ShapeOVALSize19mm
FlavorImprint Code MMD
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0682-3001-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/2000
Labeler - Marnel Pharmaceuticals, Inc. (053781795)
Establishment
NameAddressID/FEIBusiness Operations
Nexgen Pharma, Inc.160356114MANUFACTURE(0682-3001)

Revised: 5/2014
Document Id: ed775d39-46ec-4014-a727-232ab02b6f10
Set id: 34beae32-51e4-4bdc-8ca5-1d8d79f193b2
Version: 1
Effective Time: 20140502
 
Marnel Pharmaceuticals, Inc.