Precare chewables tablets

Rx Only

Description

Each orange-colored tablet contains:

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

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

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

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

Vitamin E (as dl-Alpha-Tocopheryl acetate) .....................3.5 mg 

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

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

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

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

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

Inactive Ingredients:   Citric acid, FD&C yellow No. 6 lake, flow agents, natural non-nutritive and nutritive sweetening agents, natural and artificial flavors.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

* 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.

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.

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 an elderly patient 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 tablets, debossed "Thx" on one side and "024" on the other side in child-resistant, unit dose packages of 100 tablets (10 × 10 Unit Dose Packs) (NDC 64011-024-11). Store at controlled room temperature, 15°-30°C (59°-86°F).

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

P3881 01/02

Drug Delivery Technology Provided

and Product Manufactured by

KV Pharmaceutical Co.

for Ther-Rx Corporation

St. Louis, MO 63045

U.S. Patents No. 4,822,816, 5,070,085, 5,494,681, 6,228,388 and 6,261,600

Other U.S. Patent 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.