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PreCare Prenatal Caplets (Ther-Rx)
DESCRIPTION
PreCare® Prenatal is a prescription prenatal multivitamin/mineral nutritional supplement. Each dye-free, peach film coated caplet contains:
Vitamins:
Folic Acid, USP ....................................................... 1 mg
Vitamin B 1 (thiamine mononitrate, USP) ................... 3 mg
Vitamin B 2 (riboflavin, USP) ................................. 3.4 mg
Vitamin B 3 (niacinamide) ........................................ 20 mg
Vitamin B 6 (pyridoxine HCl, USP) ......................... 50 mg
Vitamin B 12 (cyanocobalamin) ............................. 12 mcg
Vitamin C (as Ester-C ®) * ..................................... 50 mg
Vitamin D 3 (cholecalciferol) ................................... 6 mcg
Vitamin E (dl-alpha-tocopheryl acetate) ................. 3.5 IU
Minerals:
Calcium (as CalciPure™ calcium carbonate) ........ 250 mg
Copper (cupric oxide) ............................................. 2 mg
Iron (as MicroMask® ferrous fumarate) ................ 40 mg
Magnesium (magnesium oxide, USP) ..................... 50 mg
Zinc (zinc oxide, USP) ........................................... 15 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: Natural oils, natural wax, cellulose polymers, flow agents, and other ingredients. Dye free.
INDICATIONS
PreCare® Prenatal caplets are indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period - for both lactating and non-lactating mothers. 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.
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 perni-cious 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 caplet daily, or as prescribed by a physician.
HOW SUPPLIED
PreCare® Prenatal Multivitamin/ Mineral Caplets for oral administration are supplied as dye-free, peach film coated caplets, debossed "Ther-Rx" on one side and "118" with partial bisect on the other side in bottles of 30 tablets (NDC 64011-118-19). Store at controlled room temperature 15°-30° C (59°-86° F).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
P4565 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; 6,569,857.
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