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

BACMIN by

Drug Labeling and Warnings

BACMIN by is a Prescription medication manufactured, distributed, or labeled by Marnel Pharmaceuticals, Inc., Nexgen Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Vitamin/Mineral Nutritional Supplement
Rx ONLY

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.

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.

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.

SPL UNCLASSIFIED SECTION

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

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, coated

Product 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)