Pnv - Omega

Pnv - Omega
SPL v4
SPL
SPL Set ID 735c5531-137f-4cee-8c68-ae121045a8ff
Route
ORAL
Published
Effective Date 2018-02-07
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ascorbic Acid (85 mg) Cholecalciferol (200 [iU]) .alpha.-tocopherol (10 [iU]) Pyridoxine (25 mg) Folic Acid (1 mg) Cyanocobalamin (12 ug) Biotin (250 ug) Calcium Cation (140 mg) Ferrous Cation (28 mg) Iodide Ion (150 ug) Magnesium Cation (45 mg) Doconexent (300 mg) Icosapent (40 mg)
Inactive Ingredients
Yellow Wax Corn Oil Lecithin, Soybean Gelatin Glycerin Water Titanium Dioxide Fd&c Blue No. 1 Fd&c Red No. 3

Identifiers & Packaging

Pill Appearance
Imprint: 332 Shape: capsule Color: green Size: 25 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2010-08-19

Description

PNV - Omega Rx Only

Dosage and Administration

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

Contraindications

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

Adverse Reactions

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

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.


Medication Information

Dosage and Administration

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

Contraindications

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

Adverse Reactions

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

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.

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.

Section 42229-5

PNV - Omega

Rx Only

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.

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.

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.

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.

Principal Display Panel 30 Softgel Tablets

NDC 42192-332-30

PNV - Omega

Rx Prenatal Vitamin and DHA

Rx Only

30 Softgels

Acella PHARMACEUTICALS, LLC

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.


Structured Label Content

Section 42229-5 (42229-5)

PNV - Omega

Rx Only

Warning (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.

Description (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.

Indications (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.

Precautions (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.

How Supplied (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.

Adverse Reactions (ADVERSE REACTIONS)

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

Contraindications (CONTRAINDICATIONS)

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

Other Ingredients (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.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

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

Principal Display Panel 30 Softgel Tablets (PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets)

NDC 42192-332-30

PNV - Omega

Rx Prenatal Vitamin and DHA

Rx Only

30 Softgels

Acella PHARMACEUTICALS, LLC

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.


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