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PreQue 10 (vitamin a 1250 [iu] ascorbic acid 30 mg thiamine 1 mg riboflavin 1.7 mg cyanocobalamin 1 ug cholecalciferol 120 [iu] .alpha.-tocopherol 15 [iu] docusate sodium 25 mg folic acid 0.5 mg iron pentacarbonyl 15 mg cupric oxide 1 mg magnesium oxide 10 mg selenium 7.5 ug zinc oxide 12.5 mg ubidecarenone 50 mg lycopene 5 mg doconexent 50 mg) Dailymed



IMPRINT: PREQUE 10     SHAPE: oval
    COLOR: purple

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.

Boxed Warning

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.


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Description:


PreQue 10 is available by prescription only and is designed specifically to meet the extra nutritional demands of a woman before, during, and/or after pregnancy. Each slender, oblong, and coated PreQue 10 tablet is light violet in color and imprinted with “PreQue” on one side and “10” on the opposite side.

Each   PreQ u e   10   tablet   and   daily   d o se   of   two   (2)   t a blets   contains   the   following   ingredients:
  Amount per tablet   Amount per daily dose (2 tablets)
 Vitamin A (beta-carotene)  1,250 IU  2,500 IU
 Vitamin C (Pharm-C®*)  30 mg  60 mg
 Vitamin B1 (thiamine mononitrate)  1 mg  2 mg
 Vitamin B2 (riboflavin)  1.7 mg  3.4 mg
 Vitamin B12 (cyanocobalamin)  1 mcg  2 mcg
 Vitamin D3 (cholecalciferol)  120 IU  240 IU
 Vitamin E (d-alpha-tocopheryl succinate)  15 IU  30 IU
 Docusate Sodium  25 mg  50 mg
 Folic Acid  0.5 mg  1 mg
 Elemental Iron (as carbonyl iron)  15 mg  30 mg
 Copper (as cupric oxide)  1 mg  2 mg
 Magnesium (as magnesium oxide)  10 mg  20 mg
 Selenium (as sodium selenate)  7.5 mcg  15 mcg
 Zinc (as zinc oxide)  12.5 mg  25 mg
 CoQ10 (co-enzyme Q-10)  50 mg  100 mg
 Lycopene  5 mg  10 mg
 life’sDHA TM ** (docosahexaenoic acid)  50 mg  100 mg

*Pharm-C® is a proprietary blend of ascorbic acid, calcium ascorbate and sodium ascorbate.Pharm-C®  is a registered trademark of Nexgen Pharma, Inc. **life s   DHA TM   is a trademark of Martek Biosciences Corporation.

Other Ingredients: Algal oil, microcrystalline cellulose, glucose syrup solids, mannitol, pea starch, alginate, natural flavors, croscarmellose sodium, silicon dioxide, high oleic sunflower oil, sodium caseinate (milk), soy protein, ethylcellulose, stearic acid, polyvinyl alcohol, tricalcium phosphate, ascorbyl palmitate, mixed natural tocopherols, soy lecithin, tetrasodium diphosphate, povidone, arabic gum, titanium dioxide, polyethylene glycol, talc, hypromellose, magnesium stearate, sodium benzoate, tomato lipids, gelatin, sucrose, food starch, modified food starch, FD&C Blue #2 Indigo Carmine Aluminum Lake, FD&C Red #40 Allura Red AC Aluminum Lake, tocopherol concentrate, dicalcium phosphate, medium chain triglycerides.

Allergen Information: Contains milk and soy.

PreQue 10 is designed specifically to meet the extra nutritional demands of a pregnant woman. PreQue 10 contains lycopene. Lycopene is a carotenoid present in human serum and skin as well as the liver, adrenal glands, lungs, prostate, and colon. In addition to CoQ10 and lycopene, PreQue 10 has other ingredients with antioxidant properties, such as vitamin A, vitamin C, vitamin E and selenium.

Prenatal Nutrition: Good maternal nutrition is a key factor influencing the health of the mother and child. (1)

The American Dietetic Association recommends that pregnant women have appropriate weight gain, consumption of a variety of foods in accordance with the Dietary Guidelines for Americans, have appropriate and timely vitamin and mineral supplementation, and that alcohol, tobacco, and other harmful substances be avoided. (2)

Indicat


PreQue   10  is designed specifically to meet the extra nutritional demands of a woman before, during, and/or after pregnancy.

Contra


PreQue   10  is contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

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.

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.

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 1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Adverse Reactions:


Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cyanocobalamin.

CAUTION:

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Dosage


Before, during, and/or after pregnancy, two (2) tablets should be taken daily or as directed by a physician. The total daily dose (2 tablets) of PreQue 10 may be taken at one time or in divided doses.

NOTICE:

Contact with moisture can discolor or erode the tablet.

How


Bottles of 60 tablets for commercial sale (NDC 52544-079-60) with a child-resistant closure.

KEEP   OUT   OF   THE   R E ACH   OF   C HI L DR E N.

DISPEN S E   I N   A   T I GHT,   LIGHT   R E SISTA N T   C ON T AI N ER   AS   DEFI NE D   BY   T HE   USP/NF   W I TH   A CH I LD- R E S ISTA N T   C L OSU R E.

Store   at   20   to   25°C   (68   t o   77°F).  [See USP controlled room temperature.]

References:

  • Kaiser LL, Allen L. Position of the American Dietetic Association: nutrition and lifestyle for a healthy pregnancy outcome. J   Am   Diet   Assoc.  2008;108:553-561.
  • American College of Obstetricians and Gynecologists. Nutrition During Pregnancy. ACOG pamphlet number AP001. Available at: http:/ / www.acog.org/pub l ications/p a tient education/bp001. c f m accessed August 31, 2011.

To report a serious adverse event or obtain product information, call Actavis Medical Communications 1-800-272-5525.

PreQue   10  is a trademark licensed exclusively to Watson Pharma, Inc. U.S.Patent No. 7,964,189

life’s   DHA TM   is a trademark of Martek Biosciences Corporation.

Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA

7124-0014-99-OS

Rev. 09/14

Principal


PreQue 10™NDC 52544-079-60Bottle - 60 tablets



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