Mi-Omega NF

Generic Name: folic acid, pyridoxine hydrochloride, cyanocobalamin, omega-3-acid ethyl esters and sitosterol
Dosage Form: capsule

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.

Mi-Omega NF Capsules

Mi-Omega NF Description

Each capsule contains:

Folic Acid USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg

Vitamin B6 USP . . . . . . . . . . . . . . . . . . . . . . . . 12.5 mg

Vitamin B12 USP . . . . . . . . . . . . . . . . . . . . . . . 500 mcg

Omega-3 Acids . . . . . . . . . . . . . . . . . . . . . . . . . . 500 mg

Phytosterols (Plant Sterols) . . . . . . . . . . . . . . . . 200 mg

INGREDIENTS: Yellow Beeswax NF,

Ascorbyl Palmitate, Lecithin, Mixed Natural Tocopherols, and a soft shell capsule (which contains: Gelatin USP, Glycerin NF/USP, Titanium Dioxide USP, FD&C Red No. 40, Shellac Glaze USP/NF, FD&C Blue No. 1, FD&C Yellow No. 6, Propylene Glycol USP, Lecithin FCC, Simethicone USP, Silica and Purified Water, USP).

Indications and Usage for Mi-Omega NF

Mi-Omega NF Capsules are indicated for improving nutritional status in conditions requiring nutritional support and folic acid supplementation, as well as for patients where cholesterol levels are a concern.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings

Keep this and all medications out of the reach of children.

Precautions

General

This product contains fish and soy which are potential allergens. Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pediatrics: Safety and effectiveness in pediatric patients have not been established.

Pregnancy

Pregnancy and Lactation: The safety of phytosterols has not been studied in pregnant or breastfeeding women. There is no evidence that dietary intakes of naturally occurring phytosterols, such as those consumed by vegetarian women, adversely affects pregnancy or lactation.

Adverse Reactions

Allergic sensitization has been reported following oral, enteral and parenteral administration of folic acid.

Mi-Omega NF Dosage and Administration

Adults - One to four capsules daily or as directed by a physician

How is Mi-Omega NF Supplied

HOW SUPPLIED

Mi-Omega NF Capsules are supplied as red opaque oblong capsules. Each capsule is imprinted with “TP 300” in black ink. Mi-Omega NF Capsules are available in bottles of 60s, NDC 68308-502-60.

KEEP OUT OF REACH OF CHILDREN.

Dispense in a well-closed, tight light-resistant container as defined in the USP using a child-resistant closure.

Storage Conditions: Store at 20-25°C (68-77°F). See USP Controlled Room Temperature. Protect from light and moisture.

Manufactured for:

Midlothian Laboratories

Montgomery, AL 36117 USA

Rev. 4/09 7140

CONTAINER LABEL

Principal Display Panel

Mi-Omega NF 
multiple vitamin capsule capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68308-502
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 12.5 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 500 ug
OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) OMEGA-3-ACID ETHYL ESTERS 500 mg
SITOSTEROL, BETA- (SITOSTEROL, BETA-) SITOSTEROL, BETA- 200 mg
Product Characteristics
Color RED (Opaque) Score no score
Shape OVAL (Oblong) Size 20mm
Flavor Imprint Code TP;300
Contains         
Packaging
# Item Code Package Description
1 NDC:68308-502-60 60 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2009
Labeler - Midlothian Laboratories, LLC (142122824)
Revised: 12/2009
 
Midlothian Laboratories, LLC
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