ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS. Allergic sensitization has beenreported following both oral and parenteraladministration of folic acid.CAUTION: Exercise caution to ensure that theprescribed dosage of DHA does not exceed grams(1000 mg) daily.
BOXED WARNING SECTION.
WARNING: Accidental overdose of iron-containingproducts is leading cause of fatal poisoning in childrenunder 6. KEEP THIS PRODUCT OUT OF REACH OFCHILDREN. In case of accidental overdose, call doctoror poison control center immediately.
CONTRAINDICATIONS. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
DESCRIPTION. PNV-DHA Docusate is 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 FACTSServing Size: softgelAmount Per Serving Daily ValueVitamin (as ascorbic acid, USP)28 mg47%Calcium (tribasic calcium phosphate, NF)160 mg16%Iron (as ferrous fumarate, USP)27 mg150%Vitamin D3 (as cholecalciferol, USP)400 IU100%Vitamin (as d-alpha-tocopherol acetate, USP)30 IU100%Vitamin B6 (as pyridoxine HCl, USP)25 mg1250%Folic Acid, USP1.25 mg313%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.. INDICATIONS. PNV-DHA Docusate is amultivitamin/mineral prescription dietary supplementindicated for use in improving the nutritional status ofwomen prior to conception, throughout pregnancy, andin the postnatal period for both lactating andnonlactating mothers.. CONTRAINDICATIONS. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. Usual adult dose is one (1) softgel daily or as directed by physician.KEEP OUT OF REACH OF CHILDREN.
HOW SUPPLIED SECTION.
HOW SUPPLIED. PNV-DHA Docusate is supplied inchild-resistant bottles of 30 softgels (42192-323-30).The listed product number is not National DrugCode, but has merely been formatted to comply withstandard industry practice for pharmacy and insurancecomputer systems.Store at 20- 25C (68 77F); excursions permitted to15- 30C (59 86F) [See USP, Controlled RoomTemperature]. Protect from light and heat.KEEP THIS AND ALL MEDICATIONS OUT OF THEREACH OF CHILDREN.All prescription substitutions and/or recommendationsusing this product shall be made subject to state andfederal statutes as applicable. Please note: This isnot an Orange Book product and has not beensubjected to FDA therapeutic equivalency orother equivalency testing. No representation ismade as to generic status or bioequivalency.Each person recommending prescription substitutionusing this product shall make such recommendationsbased on each such persons professional opinion andknowledge, upon evaluating the dietary ingredients,other ingredients and information provided herein.THESE STATEMENTS HAVE NOT BEEN EVALUATEDBY THE FOOD AND DRUG ADMINISTRATION. THISPRODUCT IS NOT INTENDED TO DIAGNOSE,TREAT, CURE OR PREVENT ANY DISEASE.MANUFACTURED FOR:Acella Pharmaceuticals, LLC Alpharetta, GA 300221-800-541-4802Rev. 0717-01.
INACTIVE INGREDIENT SECTION.
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.
INDICATIONS & USAGE SECTION.
INDICATIONS. PNV-DHA Docusate is amultivitamin/mineral prescription dietary supplementindicated for use in improving the nutritional status ofwomen prior to conception, throughout pregnancy, andin the postnatal period for both lactating andnonlactating mothers.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL 30 Softgel Tablets. 42192-323-30PNV-DHA+DocusateRx Prenatal Vitamin and DHADietary SupplementRx Only 30 SoftgelsAcella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL Film Coated Tablets.
PRECAUTIONS. Folic acid alone is improper therapy inthe treatment of pernicious anemia and othermegaloblastic anemias where vitamin B12 is deficient.Folic acid in doses above 1.0 mg daily may obscurepernicious anemia in that hematologic remission canoccur while neurological manifestations progress.
WARNING. Ingestion of more than grams of omega-3fatty acids (such as DHA) per day has been shown tohave potential antithrombotic effects, including anincreased bleeding time and International NormalizedRatio (INR). Administration of omega-3 fatty acids shouldbe avoided in patients taking anticoagulants and in thoseknown to have an inherited or acquired predisposition tobleeding.