Mi-Omega NF Capsules

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

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.

DOSAGE AND ADMINISTRATION

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

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	Item Code (Source)	NDC:68308-502
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	12.5 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	500 ug
OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)	OMEGA-3-ACID ETHYL ESTERS	500 mg
.BETA.-SITOSTEROL (UNII: S347WMO6M4) (.BETA.-SITOSTEROL - UNII:S347WMO6M4)	.BETA.-SITOSTEROL	200 mg

Product Characteristics
Color	RED (Opaque)	Score	no score
Shape	OVAL (Oblong)	Size	20mm
Flavor		Imprint Code	TP;300
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68308-502-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2009	05/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		01/01/2009	05/31/2016

Labeler - Mayne Pharma (867220261)

Revised: 12/2017

Document Id: ae31aabb-faf7-4d38-b45b-f562c0a1bf2e

Set id: cec8bd3a-7b8d-43dd-b815-6a2daf3a1cf6

Version: 2

Effective Time: 20171211

Mayne Pharma