NDC Code(s) : 60429-616-01, 60429-617-01, 60429-618-01
Packager : Golden State Medical Supply, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Multi-Vitamin With FluorideVitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-616(NDC:64376-813)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A(UNII: 81G40H8B0T)
(VITAMIN A - UNII:81G40H8B0T) 		VITAMIN A2500 [iU]
VITAMIN D(UNII: 9VU1KI44GP)
(VITAMIN D - UNII:9VU1KI44GP) 		VITAMIN D400 [iU]
THIAMINE(UNII: X66NSO3N35)
(THIAMINE - UNII:X66NSO3N35) 		THIAMINE1.05 mg
RIBOFLAVIN(UNII: TLM2976OFR)
(RIBOFLAVIN - UNII:TLM2976OFR) 		RIBOFLAVIN1.2 mg
NIACIN(UNII: 2679MF687A)
(NIACIN - UNII:2679MF687A) 		NIACIN13.5 mg
PYRIDOXINE(UNII: KV2JZ1BI6Z)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE1.05 mg
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID0.3 mg
FLUORIDE ION(UNII: Q80VPU408O)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.25 mg
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		ASCORBIC ACID60 mg
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
(ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) 		ALPHA-TOCOPHEROL ACETATE15 [iU]
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CHOLECALCIFEROL(UNII: 1C6V77QF41)
CYANOCOBALAMIN(UNII: P6YC3EG204)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FOLIC ACID(UNII: 935E97BOY8)
GELATIN(UNII: 2G86QN327L)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
NIACINAMIDE(UNII: 25X51I8RD4)
POVIDONE(UNII: FZ989GH94E)
PYRIDOXINE(UNII: KV2JZ1BI6Z)
ORANGE(UNII: 5EVU04N5QU)
RIBOFLAVIN(UNII: TLM2976OFR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SUCROSE(UNII: C151H8M554)
THIAMINE(UNII: X66NSO3N35)
VITAMIN A ACETATE(UNII: 3LE3D9D6OY)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Product Characteristics
Color ORANGE Score no score
Shape ROUND (Flat) Size 13 mm
Flavor ORANGE Imprint Code BP;813
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-616-01100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/17/2010
Multi-Vitamin With FluorideVitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-617(NDC:64376-814)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A(UNII: 81G40H8B0T)
(VITAMIN A - UNII:81G40H8B0T) 		VITAMIN A2500 [iU]
VITAMIN D(UNII: 9VU1KI44GP)
(VITAMIN D - UNII:9VU1KI44GP) 		VITAMIN D400 [iU]
THIAMINE(UNII: X66NSO3N35)
(THIAMINE - UNII:X66NSO3N35) 		THIAMINE1.05 mg
RIBOFLAVIN(UNII: TLM2976OFR)
(RIBOFLAVIN - UNII:TLM2976OFR) 		RIBOFLAVIN1.2 mg
NIACIN(UNII: 2679MF687A)
(NIACIN - UNII:2679MF687A) 		NIACIN13.5 mg
PYRIDOXINE(UNII: KV2JZ1BI6Z)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE1.05 mg
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID0.3 mg
FLUORIDE ION(UNII: Q80VPU408O)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.50 mg
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		ASCORBIC ACID60 mg
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
(ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) 		ALPHA-TOCOPHEROL ACETATE15 [iU]
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CHOLECALCIFEROL(UNII: 1C6V77QF41)
CYANOCOBALAMIN(UNII: P6YC3EG204)
FD&C RED NO. 40(UNII: WZB9127XOA)
FOLIC ACID(UNII: 935E97BOY8)
GELATIN(UNII: 2G86QN327L)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
NIACINAMIDE(UNII: 25X51I8RD4)
POVIDONE(UNII: FZ989GH94E)
PYRIDOXINE(UNII: KV2JZ1BI6Z)
CHERRY(UNII: BUC5I9595W)
RIBOFLAVIN(UNII: TLM2976OFR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SUCROSE(UNII: C151H8M554)
THIAMINE(UNII: X66NSO3N35)
VITAMIN A ACETATE(UNII: 3LE3D9D6OY)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Product Characteristics
Color RED Score no score
Shape SQUARE (Flat) Size 13 mm
Flavor CHERRY Imprint Code BP;814
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-617-01100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/29/2010
Multi-Vitamin With FluorideVitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-618(NDC:64376-815)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A(UNII: 81G40H8B0T)
(VITAMIN A - UNII:81G40H8B0T) 		VITAMIN A2500 [iU]
VITAMIN D(UNII: 9VU1KI44GP)
(VITAMIN D - UNII:9VU1KI44GP) 		VITAMIN D400 [iU]
THIAMINE(UNII: X66NSO3N35)
(THIAMINE - UNII:X66NSO3N35) 		THIAMINE1.05 mg
RIBOFLAVIN(UNII: TLM2976OFR)
(RIBOFLAVIN - UNII:TLM2976OFR) 		RIBOFLAVIN1.2 mg
NIACIN(UNII: 2679MF687A)
(NIACIN - UNII:2679MF687A) 		NIACIN13.5 mg
PYRIDOXINE(UNII: KV2JZ1BI6Z)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE1.05 mg
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID0.3 mg
FLUORIDE ION(UNII: Q80VPU408O)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION1.0 mg
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		ASCORBIC ACID60 mg
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
(ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) 		ALPHA-TOCOPHEROL ACETATE15 [iU]
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CHOLECALCIFEROL(UNII: 1C6V77QF41)
CYANOCOBALAMIN(UNII: P6YC3EG204)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FOLIC ACID(UNII: 935E97BOY8)
GELATIN(UNII: 2G86QN327L)
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
NIACINAMIDE(UNII: 25X51I8RD4)
POVIDONE(UNII: FZ989GH94E)
PYRIDOXINE(UNII: KV2JZ1BI6Z)
GRAPE(UNII: 6X543N684K)
RIBOFLAVIN(UNII: TLM2976OFR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SUCROSE(UNII: C151H8M554)
THIAMINE(UNII: X66NSO3N35)
VITAMIN A ACETATE(UNII: 3LE3D9D6OY)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
D&C RED NO. 7(UNII: ECW0LZ41X8)
Product Characteristics
Color ORANGE Score no score
Shape ROUND (Flat) Size 13 mm
Flavor ORANGE Imprint Code BP;813
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-618-01100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/17/2010

PRINCIPAL DISPLAY PANEL

Label Graphic - 0.25 mg

PRINCIPAL DISPLAY PANEL

Label Graphic - 0.50 mg

PRINCIPAL DISPLAY PANEL

Label Graphic - 1.0 mg

[Rev 15]