DuetDHA Complete

Generic Name: prenatal multi-vitamin, multi-mineral, and omega-3 fatty acids
Dosage Form: tablet / capsule

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.

Duet®DHA Complete by StuartNatal®

Rx Only

DESCRIPTION:

Duet® DHA Complete is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acids, supplied as tablets and enteric-coated softgel capsules.

Each yellow oval Duet® Tablet* contains:

VITAMINS
A (beta carotene) 3,000 IU
C (ascorbic acid) 120 mg
D (cholecalciferol) 800 IU
E (dl-alpha tocopheryl acetate) 3 mg
B1 (thiamine mononitrate) 1.8 mg
B2 (riboflavin) 4 mg
Niacinamide 20 mg
B6 (pyridoxine hydrochloride) 50 mg
Folic acid 1 mg
B12 (cyanocobalamin) 12 mcg
 
MINERALS
Calcium (calcium carbonate) 230 mg
Iron (polysaccharide iron complex and
       sodium iron EDTA, Ferrazone®)
27 mg
Magnesium (magnesium oxide 25 mg
Zinc (zinc oxide) 25 mg
Copper (cupric oxide) 2 mg
Iodine 220 mcg

Each frosted golden-colored oval enteric-coated DHA Softgel Capsule* contains a clear solution of not less than 430 mg purified omega-3 long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid) and DPA (docasapentaenoic acid) in approximately 628 mg of fish oil.

OMEGA-3 FATTY ACIDS
Total omega-3 long-chain fatty acids No less than 430 mg
As DHA No less than 295 mg
As other omega-3 long-chain fatty acids No less than 135 mg

OTHER INGREDIENTS (Duet® Tablet): Acacia, corn starch, croscarmellose sodium, D&C Yellow No. 10, dicalcium phosphate, dl-alpha tocopherol, FD&C Yellow No. 6, food starch, gelatin, glucose, hydroxypropyl methycellulose, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium ascorbate, sodium benzoate, sorbic acid, sucrose, talc, triglycerides, titanium dioxide, xanthan gum.

OTHER INGREDIENTS (Enteric-coated DHA Softgel Capsule): Ammonium hydroxide, ethylcellulose, fractionated coconut oil, gelatin, glycerin, oleic acid, stearic acid, sodium alginate, and DHA and EPA concentrate derived from purified fish oil via a proprietary process.

*Compliance: The yellow oval Duet® Tablet is formulated in conformance with official U.S. Pharmacopeia (USP) standards of quality for potency, purity and dissolution. Duet® Tablet, as manufactured, is subject to Quality Control Standards and Good Manufacturing Practices established by the U.S. FDA. The DHA concentrate complies with The Global Organization for EPA and DHA Omega-3s (GOED) Voluntary Monograph for identity and purity. The DHA concentrate is also certified to meet Friend of the Sea Sustainable Fisheries criteria.

INDICATIONS:

Duet® DHA Complete is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. Duet® DHA Complete is also useful in improving the nutritional status prior to conception.

CONTRAINDICATIONS:

This product is contraindicated in patients with known hypersensitivity to any of the ingredients, including fish or fish oil.

WARNINGS:

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

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 a poison control center immediately.

Since daily ingestion of more than 3 grams per day of omega-3 fatty acids (including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA)) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

PRECAUTIONS:

Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive).

DRUG INTERACTIONS:

Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.

ADVERSE REACTIONS:

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

DOSAGE AND ADMINISTRATION:

Before, during and after pregnancy, one tablet and one enteric-coated softgel capsule taken by mouth daily, or as directed by a physician. The tablet and enteric-coated softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.

HOW SUPPLIED:

NDC 66479-890-30. Duet® DHA Complete is supplied in child-resistant blister cards containing 30 doses per carton (1 Duet® tablet and 1 enteric-coated DHA softgel capsule equals 1 daily dose). Each unit-of-use dispensing carton contains 5 cards with 6 unit-doses per card which is a 30-day supply. The yellow oval Duet® tablet is imprinted with the StuartNatal® logo (“heart-in-a-heart”) on one side and “885” on the other. The frosted golden-colored oval enteric-coated DHA softgel capsule is imprinted with the StuartNatal® logo (“heart-in-a-heart” outlined traced) on one side and X1 on the other.

STORAGE: Store at controlled room temperature 20-25°C (68-77°F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet.

DISPENSING: Keep in a well-closed, light-resistant container as defined by the USP. Unit dose blisters are child-resistant to opening as a safeguard against ingestion by children. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

To request medical information or to report suspected adverse reactions, contact Xanodyne Medical Affairs at 1-877-773-7793.

www.DuetDHA.com

Marketed by: Xanodyne® pharmaceuticals, inc.
         Newport, KY 41071, USA

StuartNatal, Duet, “When one heart becomes two” and the “heart-in-a-heart” logo are registered trademarks of Xanodyne Pharmaceuticals, Inc. All rights reserved.
Ferrazone® is a registered trademark of AkzoNobel b v
© 2010, Xanodyne® Pharmaceuticals, Inc.
PI-890-A     Revision 08/2010

Principal Display Panel

Blister Pack Label
Duet®DHA
Complete
Rx Only
Lot No. 12-123456
Exp. Date 09/2013
SEE WARNING ON CARTON
Xanodyne® Pharmaceuticals, inc.
Newport, KY 41071
NDC 66479-890-91

Carton Label
Rx Only
NDC 66479-890-30
when one heart
becomes two® Duet®DHA
Complete
Prescription Prenatal Vitamins
Features an innovative blend of iron
and enteric-coated omega-3
long-chain fatty acids(DHA
and EPA) for enhanced
tolerability8 30 day supply-30 tablets
And 30 softgel capsules
By StuartNatal® Gluten Free

DuetDHA Complete 
beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, iodine, omega-3 fatty acids kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66479-890
Packaging
# Item Code Package Description
1 NDC:66479-890-30 1 KIT (1 KIT) in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1
Part 2
Part 1 of 2
DuetDHA Complete 
beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, iodine tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 800 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 3 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 1.8 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 230 mg
IRON (IRON) IRON 27 mg
MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM OXIDE 25 mg
ZINC OXIDE (ZINC) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC OXIDE 2 mg
IODINE (IODINE) IODINE 220 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA  
STARCH, CORN  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
.ALPHA.-TOCOPHEROL, DL-  
FD&C YELLOW NO. 6  
GELATIN  
DEXTROSE  
HYPROMELLOSES  
LECITHIN, SOYBEAN  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POLYVINYL ALCOHOL  
SILICON DIOXIDE  
SODIUM ASCORBATE  
SODIUM BENZOATE  
SORBIC ACID  
SUCROSE  
TALC  
MEDIUM-CHAIN TRIGLYCERIDES  
TITANIUM DIOXIDE  
XANTHAN GUM  
Product Characteristics
Color yellow (yellow) Score no score
Shape OVAL (OVAL) Size 19mm
Flavor Imprint Code 885
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/26/2010 05/31/2012
Part 2 of 2
DuetDHA Complete 
omega-3 fatty acids capsule, liquid filled
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 430 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA  
ETHYLCELLULOSES  
MEDIUM-CHAIN TRIGLYCERIDES  
GELATIN  
GLYCERIN  
OLEIC ACID  
STEARIC ACID  
SODIUM ALGINATE  
Product Characteristics
Color yellow (yellow) Score no score
Shape OVAL (OVAL) Size 16mm
Flavor Imprint Code X1
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/26/2010 05/31/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/26/2010 05/31/2012
Labeler - Xanodyne Pharmaceuticals, Inc. (012921305)
Establishment
Name Address ID/FEI Operations
JLM Pharmatech, Inc. 966721805 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Accucaps Industries Limited 248441727 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Perrigo Holland, Inc. 085893071 MANUFACTURE
Revised: 05/2011
 
Xanodyne Pharmaceuticals, Inc.



Hide
(web2)