DuetDHA Balanced

Dosage Form: tablets / capsules
Duet®DHA Balanced by StuartNatal®

Rx Only

DESCRIPTION:

Duet® DHA Balanced 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)	2,850 IU
C (ascorbic acid)	120 mg
D (cholecalciferol)	840 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)	219 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 no more than 754 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 Balanced 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 Balanced 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 66479-895-30. Duet® DHA Balanced 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 “123” 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

© 2011, Xanodyne® Pharmaceuticals, Inc.

PI-895-B     Revision 01/2011

Principal Display Panel

Blister Pack Label

Duet®DHA

Balanced

Rx Only

Lot No. 99-999999

Exp. Date 99/9999

SEE WARNING ON CARTON

Xanodyne® Pharmaceuticals, inc.

Newport, KY 41071

NDC 66479-895-91

Carton Label

Rx Only

NDC 66479-895-30

when one heart

becomes two®

Duet®DHA

Balanced

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

And 430 mg

Omega-3s

DuetDHA Balanced  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 NDC Product Code (Source) 66479-895

Packaging # NDC Package Description Multilevel Packaging 1 66479-895-30 1 KIT In 1 BLISTER PACK None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1   6  Part 2   6

Part 1 of 2 DuetDHA Balanced  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 2850 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 840 [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 219 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 123 Contains

Packaging # NDC Package Description Multilevel Packaging Package Information Not Applicable

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/19/2010 02/28/2013

Part 2 of 2 DuetDHA Balanced  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

Packaging # NDC Package Description Multilevel Packaging Package Information Not Applicable

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/19/2010 02/28/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/19/2010	02/28/2013

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: 05/2011Xanodyne Pharmaceuticals, Inc.

Floraquin

Floraquin may be available in the countries listed below.

Ingredient matches for Floraquin

Diiodohydroxyquinoline

Diiodohydroxyquinoline is reported as an ingredient of Floraquin in the following countries:

• Turkey

International Drug Name Search

R-Tanna Tablets

phenylephrine tannate and chlorpheniramine tannate

Dosage Form: tablet
R-Tanna Tablets

Description

R-Tanna Tablets are an antihistamine/nasal decongestant combination. Each tablet contains:

Phenylephrine Tannate         25 mg

Chlorpheniramine Tannate      9 mg


Other ingredients: corn starch, dibasic calcium phosphate, magnesium stearate, methylcellulose, polygalacturonic acid, povidone, talc.

Clinical Pharmacology

R-Tanna Tablets combine the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of chlorpheniramine.

Indications and Usage

R-Tanna Tablets are indicated for symptomatic relief of the coryza and nasal congestion associated with the common cold, sinusitis, allergic rhinitis and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease.

Contraindications

R-Tanna Tablets are contraindicated for newborns, nursing mothers and patients sensitive to any of the ingredients or related compounds.

Warnings

Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow angle glaucoma or prostatic hypertrophy. Use with caution or avoid use in patients taking monoamine oxidase (MAO) inhibitors, or within 14 days of stopping such treatment. This product contains an antihistamine which may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers).

Precautions

General: Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients. Antihistamines may cause excitation, particularly in children, but their combination with sympathomimetics may cause either mild stimulation or mild sedation.

Information for patients: Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery while using this product. Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If patients are uncertain whether a prescription drug contains an MAOI, they should be instructed to consult a health professional before taking such a product.

Drug interactions: MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents.

Carcinogenesis, mutagenesis, impairment of fertility: No long term animal studies have been performed with R-Tanna Tablets.

Pregnancy: Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with R-Tanna Tablets. It is also not known whether R-Tanna Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. R-Tanna Tablets should be given to a pregnant woman only if clearly needed.

Nursing mothers: R-Tanna Tablets should not be administered to a nursing woman.

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Adverse effects associated with R-Tanna Tablets at recommended doses have been minimal. The most common have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare.

Overdosage

Signs and symptoms: May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent.

Treatment: Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in infants, children and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.

Dosage and Administration

Administer the recommended dose every 12 hours.

R-Tanna Tablets: Adults -- 1 or 2 tablets.

How Supplied

R-Tanna Tablets (phenylephrine tannate 25 mg, chlorpheniramine tannate 9 mg): buff-colored, capsule-shaped, and imprinted "PRASCO 534" on one side and bisected on the other side. The tablets are available in bottles of 100 (NDC 66993-534-02).


Storage: Store at controlled room temperature 20°-25°C (68°-77°F). Protect from moisture.

Dispense in a tight container.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

U.S. Patent 6,037,358

Produced under license from

JFC Technologies

Bound Brook, NJ, U.S.A.

U.S. Patents 5,599,846; 5,663,415


Mfd. For: Prasco Laboratories

             Mason, OH 45040 USA

Mfd. By: Meda Pharmaceuticals Inc.

             Somerset, New Jersey 08873-4120


Rev. 05/10

Package Label - Principal Display Panel - 100 Tablet Bottle, R-Tanna Tablets

R-TANNA  phenylephrine tannate and chlorpheniramine tannate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66993-534 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE TANNATE (PHENYLEPHRINE) PHENYLEPHRINE TANNATE 25 mg CHLORPHENIRAMINE TANNATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE TANNATE 9 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN   DIBASIC CALCIUM PHOSPHATE DIHYDRATE   MAGNESIUM STEARATE   METHYLCELLULOSE (1500 CPS)   POVIDONE   TALC

Product Characteristics Color brown (buff) Score 2 pieces Shape CAPSULE Size 15mm Flavor Imprint Code PRASCO534 Contains

Packaging # NDC Package Description Multilevel Packaging 1 66993-534-02 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/19/2005

Labeler - Prasco Laboratories (065969375)

Establishment
Name	Address	ID/FEI	Operations
Meda Pharmaceuticals, Inc.		005119771	manufacture

Revised: 08/2010Prasco Laboratories

More R-Tanna Tablets resources

• R-Tanna Tablets Side Effects (in more detail)
• R-Tanna Tablets Dosage
• R-Tanna Tablets Use in Pregnancy & Breastfeeding
• Drug Images
• R-Tanna Tablets Drug Interactions
• R-Tanna Tablets Support Group
• 2 Reviews for R-Tannas - Add your own review/rating

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UK matches:

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SPC	Summary of Product Characteristics (UK)

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Valproic Acid sodium (a derivative of Valproic Acid) is reported as an ingredient of Soval in the following countries:

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Sedacoron may be available in the countries listed below.

Ingredient matches for Sedacoron

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Amiodarone is reported as an ingredient of Sedacoron in the following countries:

• Tunisia

Amiodarone hydrochloride (a derivative of Amiodarone) is reported as an ingredient of Sedacoron in the following countries:

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Ipradol may be available in the countries listed below.

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Trigynovin may be available in the countries listed below.

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Ethinylestradiol is reported as an ingredient of Trigynovin in the following countries:

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Osetron may be available in the countries listed below.

Ingredient matches for Osetron

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Ektoban may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Ektoban

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Cymiazol is reported as an ingredient of Ektoban in the following countries:

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