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 
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.

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Se-Care Chewable

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, USP1 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
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:13925-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID50 mg
CALCIUM THREONATE (UNII: HBB4YPO93U) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM THREONATE50 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL6 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-3.5 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE2 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION250 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION40 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION50 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ORANGE JUICE (UNII: 5A9KE2L9L3)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorGRAY (pale grey-green) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code TL014
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13925-104-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/01/200908/31/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/200908/31/2011
Labeler - Seton Pharmaceuticals (828898002)
Establishment
NameAddressID/FEIBusiness Operations
VIVA253288898MANUFACTURE(13925-104)
Establishment
NameAddressID/FEIBusiness Operations
Rainbow Gold 800695152REPACK(13925-104)

Revised: 8/2016
 
Seton Pharmaceuticals