Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Calcium, Ferrous Fumarate, Doconexent
FDA Drug Information • Also known as: Pnv-Dha
- Brand Names
- Pnv-Dha
- Drug Class
- Vitamin C [EPC], Calcium [EPC], Vitamin D [EPC], Vitamin B6 Analog [EPC]
- Route
- ORAL
- Dosage Form
- CAPSULE, GELATIN COATED
- Product Type
- HUMAN PRESCRIPTION DRUG
⚠ Boxed Warning (Black Box)
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.
Description
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 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.
What Is Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Calcium, Ferrous Fumarate, Doconexent Used For?
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 and Administration
DOSAGE AND ADMINISTRATION Usual adult dose is one (1) softgel daily or as directed by a physician. KEEP OUT OF REACH OF CHILDREN.
Side Effects (Adverse Reactions)
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.
Warnings and 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.
Contraindications
CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
How Supplied
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
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.