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PNV - Omega | PNV-Omega [Acella Pharmaceuticals, LLC] | BioPortfolio

13:40 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Rx Only

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.

Supplement Facts
Serving Size 1 Softgel
Amount Per
Serving
% DV %DV for Pregnant
or Lactating
Women
Vitamin C 85 mg 142% 142%
Vitamin D3 200 IU 50% 50%
Vitamin E 10 IU 33% 33%
Vitamin B6 25 mg 1250% 1000%
Folate 1 mg 250% 125%
from ((6S)-N5-Methyl-Tetrahydrofolic acid calcium salt 600 mcgPercent Daily Values are based on a 2000 calorie diet)
and (folic acid, USP 400 mcg) (no more than 10% D-Isomer))
Vitamin B12 12 mcg 200% 150%
Biotin 250 mcg 83% 83%
Calcium (calcium carbonate) 140 mg 14% 11%
Iron (ferrous fumarate) 28 mg 156% 156%
Iodine (potassium iodide) 150 mcg 100% 100%
Magnesium (magnesium oxide) 45 mg 11% 10%
Docosahexaenoic Acid (DHA) 300 mg Daily Value (DV) not established
Eicosapentaenoic Acid (EPA)
(from 340 mg omega-3 fatty acids from fish oil)
40 mg

bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3. Sugar, lactose, yeast and gluten free.

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 nutritionalsupplementation.

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

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.

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.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 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.

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

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

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) [See USP].

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 30022 1-800-541-4802

Rev. 0515-01

NDC 42192-332-30

PNV - Omega

Rx Prenatal Vitamin and DHA

Rx Only

30 Softgels

Acella PHARMACEUTICALS, LLC

Manufacturer

Acella Pharmaceuticals, LLC

Active Ingredients

Source

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