Se-Care Chewable (calcium ascorbate 50 mg calcium threonate 50 mg cholecalciferol 6 ug .alpha.-tocopherol acetate, dl- 3.5 [iu] pyridoxine hydrochloride 2 mg folic acid 1 mg calcium carbonate 250 mg ferrous fumarate 40 mg magnesium oxide 50 mg zinc oxide 15 mg cupric oxide 2 mg) Dailymed

R_x Only

Description:

Se-Care Chewable is a prescription prenatal multivitamin/mineral nutritional supplement tablet. Each pale grey-green, flavored, round, chewable tablet for oral administration contains:

Vitamins:
Vitamin C Complex* (as calcium ascorbate and calcium threonate)	50 mg
Vitamin D3 (cholecalciferol)	6 mcg
Vitamin E (dl-alpha-tocopheryl acetate)	3.5 IU
Vitamin B6 (pyridoxine hydrochloride)	2 mg
Folic Acid, USP	1 mg
Minerals:
Calcium (calcium carbonate)	250 mg
Iron (masked coated ferrous fumarate)	40 mg
Magnesium (magnesium oxide)	50 mg
Zinc (zinc oxide)	15 mg
Copper (cupric oxide)	2 mg

*Vitamin C Complex is a pharmaceutical grade material consisting of calcium ascorbate and calcium threonate.

Inactive Ingredients: Sucrose, Stevia, Fumed Silica, Orange Juice, Magnesium Stearate, Natural Orange Flavor Powder, Stearic Acid and Gelatin.

Indications:

Se-Care Chewable Tablets 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 B₁₂ is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

BOXED WARNING SECTION

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:

Pediatric Use:

Safety and effectiveness in pediatric patients have 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:

Se-Care Chewable Tablets are pale grey-green, flavored, round, debossed "TL014" packaged in bottles of 30 tablets. NDC 13925-104-30.

PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP.

Storage:

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]

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

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

R_x Only

Manufactured For: Seton PharmaceuticalsManasquan, NJ 08736 1-800-510-3401

Rev. 4/09

SETON PHARMACEUTICALS

Package Label.principal Display Panel

NDC 13925-104-30

Se-Care Chewable

Multivitamin / mineral prenatal nutritional supplement

30 Tablets

R_x Only

SETON PHARMACEUTICALS