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Primacare am capsules

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 white, dye-free, soft gelatin capsule containing the following ingredients:

Essential Fatty Acids (as OmegaNate™)
  Omega-3 Fatty Acids ............................................................
150 mg
  Linoleic Acid .........................................................................
25 mg
  Linolenic Acid .......................................................................
25 mg
Vitamins:
  Vitamin D 3 (as cholecalciferol) ..............................................
170 IU
  Vitamin E (dl-alpha-tocopheryl acetate) .................................
30 IU
Minerals:
  Calcium (as calcium carbonate) ..............................................
150 mg

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

Vitamins:
  Biotin ....................................................................................
35 mcg
  Folic Acid, USP ....................................................................
1 mg
  Vitamin B 1 / Thiamine (as thiamine mononitrate,  USP) ..........
3 mg
  Vitamin B 2 / Riboflavin, USP .................................................
3.4 mg
  Vitamin B 3 / Niacin (as niacinamide, USP) .............................
20 mg
  Vitamin B 6 / Pyridoxine (as pyridoxine HCl,  USP) ................
10 mg
  Vitamin B 12 / Cyanocobalamin ..............................................
12 mcg
  Vitamin C (as Ester-C ) * ...................................................
100 mg
  Vitamin D 3 (as cholecalciferol) ..............................................
230 IU
  Vitamin K .............................................................................
90 mcg
  Pantothenic Acid ...................................................................
7 mg
Minerals:
  Calcium (as CalciPure™ calcium carbonate) ..........................
250 mg
  Chromium .............................................................................
45 mcg
  Copper (as cupric oxide) .......................................................
1.3 mg
  Iron (as MicroMask™ ferrous fumarate) ...............................
30 mg
  Molybdenum .........................................................................
50 mcg
  Selenium ...............................................................................
75 mcg
  Zinc (as zinc oxide, USP) ......................................................
11 mg

* Ester-C is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. Ester-C is a licensed trademark of Zila Nutraceuticals, Inc..

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

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.

WARNING

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

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 cards containing 2 × 5 tablets in a 30-day supply unit-of-use dispensing carton) as follows: PrimaCare capsules are supplied as white, dye-free, soft gelatin capsules, imprinted "Ther-Rx" on one side in pink ink. PrimaCare tablets are supplied as pink, dye-free, film coated tablets, debossed "Ther-Rx" on one side and "119" with partial bisect on the other side. (NDC 64011-015-31). Store at controlled room temperature 15°-30° C (59°-86° F).

P3846-3    12/02

Tablet Manufacturer: KV Pharmaceutical Co.

Capsule Manufacturer: Accucaps Industries, Ltd.-Canada

for Ther-Rx Corporation

St. Louis, MO 63045

U.S. Patent Nos. 4,822,816. 5,070,085. 5,494,681. 5,945,123. 6,214,379. 6,258,846. 6,375,956. Other U.S. Patents Pending

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.
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