PNV-Omega

PNV-OMEGA- ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin coated
Acella Pharmaceuticals, LLC

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.

PNV — Omega

Rx Only

DESCRIPTION

PNV-Omega is a prescription prenatal/postnatal dietary supplement softgel capsule that contains multivitamins and minerals along with essential fatty acids. Each softgel is green in color, opaque and imprinted with “332” on one side.

facts
(click image for full-size original)

OTHER INGREDIENTS

Gelatin capsule (bovine gelatin, glycerin, purified water, titanium dioxide, FD&C Yellow #5, FD&C Blue #1, and FD&C Yellow #6), soy lecithin, vegetable shortening, and yellow beeswax. Contains soy. Contains FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6.

INDICATIONS

PNV — Omega is a multivitamin/ multimineral dietary supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

CONTRAINDICATIONS

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

WARNING

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTIONS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS

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

DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

HOW SUPPLIED

PNV — Omega is supplied in child-resistant bottles of 30 softgels (42192-332-30). The listed product is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the dietary ingredients, other ingredients and information provided herein.
THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

MANUFACTURED FOR:

Acella Pharmaceuticals, LLC

Alpharetta, GA 30005

1-800-541-4802

Rev 1218-04

PRINCIPAL DISPLAY PANEL — 30 Softgel Tablets

NDC 42192-332-30

PNV — Omega

Rx Prenatal Vitamin and DHA

Rx Only

30 Softgels

Acella PHARMACEUTICALS, LLC

Omega
(click image for full-size original)
PNV-OMEGA
ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, cyanocobalamin, calcium corbonate, ferrous fumarate, potassium iodide, magnesium, doconexent, icosapent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-332
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 85 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 200 [iU]
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 10 [iU]
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
BIOTIN (BIOTIN) BIOTIN 250 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 140 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 28 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 150 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 45 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 40 mg
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX
CORN OIL
LECITHIN, SOYBEAN
GELATIN
GLYCERIN
WATER
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
Product Characteristics
Color green Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code 332
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42192-332-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/19/2010
Labeler — Acella Pharmaceuticals, LLC (825380939)
Establishment
Name Address ID/FEI Operations
Acella Pharmaceuticals, LLC 825380939 manufacture (42192-332)

Revised: 06/2019 Acella Pharmaceuticals, LLC

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