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PNV-DHA Prenatal Vitamins

Generic Name: ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium and doconexent
Dosage Form: capsule, gelatin coated

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.

PNV-DHA

Rx Only

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.

*
Percent Daily Values are based on a 2000 calorie diet
Daily Value (DV) not established
Supplement Facts
Serving Size 1 Tablet
Amount Per
Serving
% DV %DV for Pregnant
or Lactating
Women
Vitamin C 85 mg 142% 142%
Vitamin D3 200 IU 50% 50%
Vitamin E 10 IU 33% 33%
Vitamin D6 25 mg 1250% 1000%
Folate 1 mg 250% 125%
(L-methylfolate calcium 676 mcg (as Xolafin-B™*)
molar equivalent to 600 mcg of Folic Acid)
(folic acid, USP 400 mcg)
Vitamin B12 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

OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3.

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: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

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: 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: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

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.]

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

PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets

NDC 42192-321-30

PNV-DHA

Rx Prenatal Vitamin and DHA

Rx Only           30 Softgels

Acella
PHARMACEUTICALS, LLC

PNV-DHA 
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42192-321
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 85 [iU]
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 200 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 25 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM (CALCIUM) CALCIUM 140 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
MAGNESIUM (MAGNESIUM) MAGNESIUM 45 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
CORN OIL  
LECITHIN, SOYBEAN  
GELATIN  
GLYCERIN  
WATER  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
FD&C RED NO. 3  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code BP;321
Contains         
Packaging
# Item Code Package Description
1 NDC:42192-321-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/02/2009
Labeler - Acella Pharmaceuticals, LLC (825380939)
Revised: 04/2013
 
Acella Pharmaceuticals, LLC



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