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  5. Label Information: Pnv-omega

FDA Label for Pnv-omega

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION
    3. OTHER INGREDIENTS
    4. INDICATIONS
    5. CONTRAINDICATIONS
    6. WARNING
    7. PRECAUTIONS
    8. ADVERSE REACTIONS
    9. DOSAGE AND ADMINISTRATION
    10. HOW SUPPLIED
    11. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
    12. PRINCIPAL DISPLAY PANEL - 30 SOFTGEL TABLETS

Pnv-omega Product Label

The following document was submitted to the FDA by the labeler of this product Acella Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Rx Only

MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30022
1-800-541-4802

Rev. 0515-01


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.

Supplement Facts
Serving Size 1 Softgel
Amount Per
Serving 		% DV %DV for Pregnant
or Lactating
Women
Vitamin C85 mg142%142%
Vitamin D3200 IU50%50%
Vitamin E10 IU33%33%
Vitamin B625 mg1250%1000%
Folate1 mg250%125%
from ((6S)-N5-Methyl-Tetrahydrofolic acid calcium salt 600 mcg

Percent Daily Values are based on a 2000 calorie diet

)
and (folic acid, USP 400 mcg) (no more than 10% D-Isomer))
Vitamin B1212 mcg200%150%
Biotin250 mcg83%83%
Calcium (calcium carbonate)140 mg14%11%
Iron (ferrous fumarate)28 mg156%156%
Iodine (potassium iodide)150 mcg100%100%
Magnesium (magnesium oxide)45 mg11%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

Other Ingredients



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.


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 nutritionalsupplementation.


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.

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 B12 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) [See USP].


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.


Principal Display Panel - 30 Softgel Tablets



NDC 42192-332-30

PNV - Omega

Rx Prenatal Vitamin and DHA

Rx Only

30 Softgels

Acella PHARMACEUTICALS, LLC


* Please review the disclaimer below.