TRICARE PRENATAL- ascorbic acid, cholecalciferol, dl-.alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric sulfate tablet, coated

TRICARE PRENATAL by

Drug Labeling and Warnings

TRICARE PRENATAL by is a Prescription medication manufactured, distributed, or labeled by Medecor Pharma, LLC, Catalent Australia PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION:

Each light blue film coated tablet contains:

• Vitamin C (Ascorbic Acid): 100 mg
• Vitamin D-3 (Cholecalciferol): 400 IU
• Vitamin E (dl-Alpha Tocopheryl Acetate): 30 IU
• Vitamin B-1 (Thiamine HCl): 1.6 mg
• Vitamin B-2 (Riboflavin): 1.6 mg
• Niacin (Niacinamide): 20 mg
• Vitamin B-6 (Pyridoxine HCl): 3.1 mg
• Folic Acid: 1 mg
• Vitamin B-12 (Cyanocobalamin): 12 mcg
• Calcium (Calcium Carbonate): 200 mg
• Iron (Ferrous Fumarate): 27 mg
• Zinc (Zinc Oxide): 10 mg
• Copper (Cupric Sulfate): 2 mg

INDICATIONS AND USAGE:

TriCare® Prenatal tablets are indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother.  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.

BOXED WARNING

(What is this?)

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 right away.

GENERAL PRECAUTIONS

Folic acid alone is improper therapy in the treatment of prenicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.

PRECAUTIONS:

Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION:

One tablet daily or as directed by a physician.

HOW SUPPLIED:

TriCare® Prenatal Multivitamin/Mineral Tablets for oral administration are supplied as light blue, film coated tablets, debossed MP 101 with a partial bisect through the tablets on one side.  In a child resistant plastic bottle of 100 tablets (NDC: 67112-101-00).

OTHER INGREDIENTS:

acacia, croscarmellose sodium, dicalcium phosphate, FD&C blue #1 Lake, FD&C blue #2 Lake, FD&C red #40 Lake, gelatin, hypromellose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyvinylpyrrolidone, silica, sodium lauryl sulfate, soy polysaccharide, stearic acid, titanium dioxide, and triacetin.

STORAGE AND HANDLING

Store at controlled room temperature, 15o-30oC (59o-86oF)

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

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

Marketed by Medecor Pharma LLC, Baton Rouge, LA  70802

PRINCIPAL DISPLAY PANEL:

NDC: 67112-101-00

TriCare

PRENATAL

Multivitamin/Mineral

Film Coated Tablet

Complete Nutritional Needs of Women

100 TABLETS

• Preconception
• Pregnancy
• Postnatal

Rx Only

INGREDIENTS AND APPEARANCE

TRICARE PRENATAL 
ascorbic acid, cholecalciferol, dl-.alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric sulfate tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 67112-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL ACETATE, DL- - UNII:WR1WPI7EW8)	.ALPHA.-TOCOPHEROL ACETATE, DL-	30 [iU]
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE - UNII:X66NSO3N35)	THIAMINE HYDROCHLORIDE	1.6 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.6 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	3.1 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7)	FERROUS FUMARATE	27 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	10 mg
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC SULFATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	blue (light blue)	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	MP;101
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67112-101-00	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/11/2002

Labeler - Medecor Pharma, LLC (830621046)

Registrant - Medecor Pharma, LLC (830621046)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Australia PTY LTD		753617638	manufacture