Drug Facts
Composition & Profile
Identifiers & Packaging
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 42192-323-30 PNV-DHA+Docusate R x Prenatal Vitamin and DHA Dietary Supplement R x Only 30 Softgels Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - Film Coated Tablets
- 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 42192-323-30 PNV-DHA+Docusate R x Prenatal Vitamin and DHA Dietary Supplement R x Only 30 Softgels Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - Film Coated Tablets
Overview
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 Value Vitamin 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 D 3 (as cholecalciferol, USP) 400 IU 100% Vitamin E (as d-alpha-tocopherol acetate, USP) 30 IU 100% Vitamin B 6 (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. INDICATIONS PNV-DHA + Docusate is a multivitamin/mineral prescription dietary supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers. CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Indications & Usage
INDICATIONS PNV-DHA + Docusate is a multivitamin/mineral prescription dietary supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
Dosage & Administration
Usual adult dose is one (1) softgel daily or as directed by a physician. KEEP OUT OF REACH OF CHILDREN.
Warnings & Precautions
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.
Boxed Warning
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.
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. CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 grams (1000 mg) daily.
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