Pnv - Omega
735c5531-137f-4cee-8c68-ae121045a8ff
34391-3
HUMAN PRESCRIPTION DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T11:39:56.447859 · Updated: 2026-03-14T22:00:09.664892