Bacmin
FDA Label NDC 0682-3001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marnel Pharmaceuticals, Inc. for the product Bacmin (NDC 0682-3001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, description, indications, contraindications, warnings, drug and treatment interactions, adverse reactions, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Description

→ Indications

→ Contraindications

→ Warnings

→ Drug And Treatment Interactions

→ Adverse Reactions

→ Dosage And Administration

→ How Supplied

→ Principal Display Panel - 100 Caplet Bottle Label

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.

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.