Se-Care Chewable

SE-CARE CHEWABLE- calcium ascorbate, calcium threonate, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide and cupric oxide tablet, chewable
Seton Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx 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.

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.

Rx Only

Manufactured For:
Seton Pharmaceuticals
Manasquan, 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

Rx Only

SETON PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL -- 30 Chewable
(click image for full-size original)
SE-CARE CHEWABLE
ascorbic acid, calcium threonate, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide and cupric oxide tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13925-104
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 50 mg
CALCIUM THREONATE (THREONINE) THREONINE 50 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 6 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 3.5 [iU]
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 2 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CALCIUM CARBONATE (CALCIUM) CALCIUM 250 mg
FERROUS FUMARATE (IRON) IRON 40 mg
MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM 50 mg
ZINC OXIDE (ZINC) ZINC 15 mg
CUPRIC OXIDE (COPPER) COPPER 2 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
STEVIA REBAUDIUNA LEAF
SILICON DIOXIDE
ORANGE JUICE
MAGNESIUM STEARATE
STEARIC ACID
GELATIN
Product Characteristics
Color GRAY (pale grey-green) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code TL014
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13925-104-30 30 TABLET, CHEWABLE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2009
Labeler — Seton Pharmaceuticals (828898002)
Establishment
Name Address ID/FEI Operations
VIVA 253288898 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Rainbow Gold 800695152 REPACK

Revised: 07/2011 Seton Pharmaceuticals

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