Other
Rx Only
MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30022
1-800-541-4802
Rev. 0515-01
Pnv-omega Capsule, Gelatin Coated
FDA Label NDC 42192-332
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acella Pharmaceuticals, Llc for the product Pnv-omega (NDC 42192-332). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, description, other ingredients, indications, contraindications, warning, precautions, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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 mcg Percent 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 | ||
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
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