Label: PNV-DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent capsule, gelatin coated
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- NDC Code(s): 42192-323-30
- Packager: Acella Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated September 12, 2018
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DESCRIPTION
PNV-DHA + Docusate is a prescription prenatal/postnatal multivitamin/multimineral softgel with DHA. Each softgel is red in color and imprinted with “323” on one side.
† Daily Value (DV) not established.
SUPPLEMENT FACTS Serving Size: 1 softgel Amount Per
Serving% Daily
ValueVitamin C (as ascorbic acid, USP) 28 mg 47% Calcium (tribasic calcium phosphate, NF) 160 mg 16% Iron (as ferrous fumarate, USP) 27 mg 150% Vitamin D3 (as cholecalciferol, USP) 400 IU 100% Vitamin E (as d-alpha-tocopherol acetate, USP) 30 IU 100% Vitamin B6 (as pyridoxine HCl, USP) 25 mg 1250% Folic Acid, USP 1.25 mg 313% DHA (docosahexaenoic acid) 300 mg † Docusate sodium, USP 55 mg † OTHER INGREDIENTS
Bovine Gelatin, Glycerin, Soybean Oil, Soy Lecithin, Purified Water, Yellow Beeswax, FD&C Red # 40, Titanium Dioxide, Orange Cream Flavor, Ethyl Vanillin, FD&C Yellow # 6, and FD&C Blue #1. Contains soy.
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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.
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- PRECAUTIONS
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
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HOW SUPPLIED
PNV-DHA + Docusate is supplied in child-resistant bottles of 30 softgels (42192-323-30). The listed product number 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”]. Protect from light and heat.
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.
MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30022
1-800-541-4802
Rev. 0717-01 - PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets
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INGREDIENTS AND APPEARANCE
PNV-DHA
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent capsule, gelatin coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-323 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 28 mg CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM 160 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 30 [iU] PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 25 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1.25 mg DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 300 mg Inactive Ingredients Ingredient Name Strength GELATIN TYPE B BOVINE (230 BLOOM) (UNII: WIL1404U79) GLYCERIN (UNII: PDC6A3C0OX) SOYBEAN OIL (UNII: 241ATL177A) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WATER (UNII: 059QF0KO0R) YELLOW WAX (UNII: 2ZA36H0S2V) FD&C RED NO. 40 (UNII: WZB9127XOA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ORANGE (UNII: 5EVU04N5QU) ETHYL VANILLIN (UNII: YC9ST449YJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color RED Score no score Shape CAPSULE Size 25mm Flavor Imprint Code 323 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42192-323-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2010 Labeler - Acella Pharmaceuticals, LLC (825380939) Establishment Name Address ID/FEI Business Operations Acella Pharmaceuticals, LLC 825380939 manufacture(42192-323)
