FDA Label for Pnv-dha
View Indications, Usage & Precautions
Pnv-dha Product Label
The following document was submitted to the FDA by the labeler of this product Acella Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Rx Only
| Supplement Facts | |||
|---|---|---|---|
| Serving Size 1 Tablet | |||
| Amount Per
Serving | % DV | %DV for Pregnant
or Lactating Women | |
| Vitamin C | 85 mg | 142% | 142% |
| Vitamin D 3 | 200 IU | 50% | 50% |
| Vitamin E | 10 IU | 33% | 33% |
| Vitamin D 6 | 25 mg | 1250% | 1000% |
| Folate | 1 mg | 250% | 125% |
| (L-methylfolate calcium 676 mcg (as Xolafin-B™
Percent Daily Values are based on a 2000 calorie diet )molar equivalent to 600 mcg of Folic Acid) | |||
| (folic acid, USP 400 mcg) | |||
| Vitamin B 12 | 12 mcg | 200% | 150% |
| Calcium | 140 mg | 14% | 11% |
| Iron (ferrous fumarate) | 27 mg | 150% | 150% |
| Magnesium | 45 mg | 11% | 10% |
| Docosahexaenoic Acid (DHA)
(from omega-3 fatty acids) | 300 mg | Daily Value (DV) not established | |
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 active ingredients, excipients, inactive ingredients and chemical information provided herein.
MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802
Rev. 04/10v6
*Xolafin-B™ is a trademark of Acella Pharmaceuticals, LLC
Description
DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque and imprinted with “BP 321” on one side.
Inactive Ingredient
OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3.
Indications & Usage
INDICATIONS: PNV-DHA is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
Contraindications
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Warnings
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
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.
Precautions
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 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.
Adverse Reactions
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
How Supplied
HOW SUPPLIED: PNV-DHA is supplied in child-resistant bottles of 30 softgels (NDC# 42192-321-30).
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
Principal Display Panel - 30 Softgel Tablets
NDC 42192-321-30
PNV-DHA
Rx Prenatal Vitamin and DHA
Rx Only 30 Softgels
Acella
PHARMACEUTICALS, LLC
* Please review the disclaimer below.