PreCare Chewables Tablets (Ther-Rx)

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DESCRIPTION

PreCare® Chewables are prescription prenatal multivitamin/mineral nutritional supplement tablets. Each orange colored, flavored, oval, chewable tablet contains:

Vitamins:

Folic Acid, USP ...................................................... 1 mg  

Vitamin B ₆ (pyridoxine HCl) .................................... 2 mg  

Vitamin C (as Ester-C ®) *  ..................................... 50 mg  

Vitamin D ₃ (cholecalciferol) .................................... 6 mcg

Vitamin E (dl-alpha-tocopheryl acetate) .................. 3.5 IU  

Minerals:

Calcium (calcium carbonate) ................................. 250 mg  

Copper (cupric oxide) .............................................. 2 mg  

Iron (including MicroMask® ferrous fumarate) ....... 40 mg  

Magnesium (magnesium oxide, USP) ...................... 50 mg  

Zinc (zinc oxide, USP) ............................................ 15 mg  

Inactive Ingredients:    Citric acid, FD&C yellow #6 lake, flow agents, natural and artificial non-nutritive and nutritive sweetening agents, natural and artificial flavors.

INDICATIONS

PreCare® Chewables are indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period - for both lactating and non-lactating mothers. They are also useful for improving nutritional status prior to conception.

CONTRAINDICATIONS

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

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B ₁₂ is deficient.

PRECAUTIONS

Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

PEDIATRIC USE:    Safety and effectiveness in pediatric patients has not been established.

GERIATRIC USE:    Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

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

DOSAGE AND ADMINISTRATION

Usual dosage is one tablet daily, or as prescribed by a physician.

HOW SUPPLIED

PreCare® Chewable tablets for oral administration are supplied as orange colored, flavored, oval tablets, debossed "Thx" on one side and "024" on the other side in bottles of 30 tablets (NDC 64011-024-19). Store at controlled room temperature 15°-30°C (59°-86°F).

Notice:    Contact with moisture may produce surface discoloration or erosion of the tablet.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

P4575 07/04

Mktd. by Ther-Rx Corp.

St. Louis, MO 63044

U.S. Patent Nos.:

4,822,816; 5,070,085; 5,494,681; 6,197,329; 6,228,388; 6,261,600; 6,352,713; 6,569,857.

Other U.S. Patent Pending

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