PrimaCare AM Capsules, PrimaCare PM Tablets (Ther-Rx)

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DESCRIPTION

PrimaCare® is a prescription prenatal/ postnatal multivitamin/mineral capsule and tablet combination with essential fatty acids that consists of two dosage forms on each blister card designated as AM and PM, as follows:

AM dose is a dye-free, white soft gelatin capsule containing the following ingredients:

Essential Fatty Acids (as OmegaNate™):

  Vitamins:

Minerals:

PM dose is a dye-free, oval shaped, pink film coated tablet containing the following ingredients:

Vitamins:

Minerals:

Inactive Ingredients:    Capsule: Natural wax, natural oils, and other ingredients. Dye free. Tablet: Cellulose polymers, flow agents, natural wax, natural oils, flavor, and other ingredients. Dye free.

INDICATIONS

PrimaCare® is indicated to provide vitamin/mineral and essential fatty acid supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. It is 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

PrimaCare®'s patented Chronometric System™ dosing regimen, consisting of one "AM" dose taken in the morning and one "PM" dose taken at night, should be followed for improved nutrient absorption potential, or as prescribed by a physician.

HOW SUPPLIED

PrimaCare® is supplied as a morning and evening oral dosing regimen in child-resistant, unit-dose blister cards of 5 soft gelatin capsules and 5 tablets (6 unit-dose packs of 2 × 5 cards in a 30-day supply unit-of-use dispensing carton) as follows: PrimaCare® capsules are supplied as dye-free, white soft gelatin capsules, imprinted "Ther-Rx 145" on one side in pink ink. PrimaCare® tablets are supplied as dye-free, oval shaped, pink film coated tablets, debossed "Ther-Rx" on one side and "144" with partial bisect on the other side. (NDC 64011-146-28). Store at controlled room temperature 15°-30° C (59°-86° F).

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

P4502      06/04

Mktd. by Ther-Rx Corp., St. Louis, MO 63044

U.S. Patent Nos.: 4,822,816; 5,070,085; 5,494,681; 5,945,123; 6,197,329; 6,214,379; 6,228,388; 6,258,846; 6,375,956; 6,488,956; 6,569,857; 6,576,666.

Other U.S. Patents Pending

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