4 mg daily dose - food and drug administration · eisai inc., woodcliff lake, nj 07677 made in...
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4 m
g da
ily d
ose
4 mg daily dose
Rx only
4 mg daily dose
NDC 62856-704-30NDC 62856-704-30
Rx only
30 D
ay S
uppl
y
4 mg daily dose
4 mg daily-dose carton containing 6 cards (five 4 mg capsules per card)
30 Day Supply
Take one “Daily Dose” of 4 mg each day
203976
Each daily dose consists of 1 capsule: one 4 mg capsule (total dose 4 mg). Each capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinibmesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
Take one 4 mg capsule once daily
®
®
®
®
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
123247
1 2 3 2 4 7
INSIDE TOP FLAP PRINTING
UNVARNISHED LOT/EXP AREA
(b) (4)
8 m
g da
ily d
ose
203972
Rx only NDC 62856-708-30NDC 62856-708-30
Rx only
8 mg daily dose
30 D
ay S
uppl
y
8 mg daily dose
8 mg daily-dose carton containing 6 cards (ten 4 mg capsules per card)
30 Day Supply
Take one “Daily Dose” of 8 mg each day
®
®
®
Take two 4 mg capsules once daily
8 mg daily dose
Each daily dose consists of 2 capsules: two 4 mg capsules (total dose 8 mg). Each capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: two 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
®
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
123243
1 2 3 2 4 3
INSIDE TOP FLAP PRINTING
UNVARNISHED LOT/EXP AREA
(b) (4)
10 m
g da
ily d
ose
10 mg daily dose
Rx only
10 mg daily dose
NDC 62856-710-30NDC 62856-710-30
Rx only
30 D
ay S
uppl
y
10 mg daily dose
10 mg daily-dose carton containing 6 cards (five 10 mg capsules per card)
30 Day Supply
Take one “Daily Dose” of 10 mg each day
203974
Each daily dose consists of 1 capsule: one 10 mg capsule (total dose 10 mg). Each capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinibmesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: one 10 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
Take one 10 mg capsule once daily
®
®
®
®
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
123237
1 2 3 2 3 7
INSIDE TOP FLAP PRINTING
UNVARNISHED LOT/EXP AREA
(b) (4)
203970
Rx only NDC 62856-712-30NDC 62856-712-30
Rx only
12 mg daily dose
12 mg daily-dose carton containing 6 cards (fifteen 4 mg capsules per card)
30 Day Supply
12 m
g da
ily d
ose
30 D
ay S
uppl
y
12 mg daily dose
Take one “Daily Dose” of 12 mg each day
12 mg daily dose
Each daily dose consists of 3 capsules: three 4 mg capsules (total dose 12 mg). Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: three 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
®
®
®
®
Take three 4 mg capsules once daily
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
INSIDE TOP FLAP PRINTING
UNVARNISHED LOT/EXP AREA
123249
1 2 3 2 4 9
(b) (4)
14 m
g da
ily d
ose
203966
Rx only NDC 62856-714-30NDC 62856-714-30
Rx only
14 mg daily dose
30 D
ay S
uppl
y
14 mg daily dose
14 mg daily-dose carton containing 6 cards (five 10 mg capsules and five 4 mg capsules per card)
30 Day Supply
Take one “Daily Dose” of 14 mg each day
14 mg daily dose
Each daily dose consists of 2 capsules: one 10 mg capsule and one 4 mg capsule (total dose 14 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: one 10 mg capsule and one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
®
®
®
®
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
Take one 10 mg capsule and one4 mg capsule together once daily
INSIDE TOP FLAP PRINTING
UNVARNISHED LOT/EXP AREA
123239
1 2 3 2 3 9
(b) (4)
Each daily dose consists of 3 capsules: one 10 mg capsule and two 4 mg capsules (total dose 18 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: one 10 mg capsule and two 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
203968
Rx only NDC 62856-718-30NDC 62856-718-30
Rx only
18 mg daily dose
18 mg daily-dose carton containing 6 cards (five 10 mg capsules and ten 4 mg capsules per card)
30 Day Supply
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
18 mg daily dose
18 m
g da
ily d
ose
30 D
ay S
uppl
y
18 mg daily dose
Take one “Daily Dose” of 18 mg each day
®
®
®
®
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
Take one 10 mg capsule and two4 mg capsules together once daily
INSIDE TOP FLAP PRINTING
UNVARNISHED LOT/EXP AREA
123245
1 2 3 2 4 5
(b) (4)
20 m
g da
ily d
ose
203964
Rx only NDC 62856-720-30NDC 62856-720-30
Rx only
20 mg daily dose
30 D
ay S
uppl
y
20 mg daily dose
20 mg daily-dose carton containing 6 cards (ten 10 mg capsules per card)
30 Day Supply
Take one “Daily Dose” of 20 mg each day
20 mg daily dose
Each daily dose consists of 2 capsules: two 10 mg capsules (total dose 20 mg). Each capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: two 10 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
®
®
®
®
Take two 10 mg capsules once daily
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
123241
N 36285672030
4
1 2 3 2 4 1
INSIDE TOP FLAP PRINTING
UNVARNISHED LOT/EXP AREA
(b) (4)
203962
Rx only NDC 62856-724-30NDC 62856-724-30
Rx only
24 mg daily dose
24 mg daily-dose carton containing 6 cards (ten 10 mg capsules and five 4 mg capsules per card)
30 Day Supply
24 m
g da
ily d
ose
30 D
ay S
uppl
y
24 mg daily dose
Take one “Daily Dose” of 24 mg each day
24 mg daily dose
Each daily dose consists of 3 capsules: two 10 mg capsules and one 4 mg capsule (total dose 24 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: two 10 mg capsules and one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
®
®
®
®
Take two 10 mg capsules and one4 mg capsule together once daily
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
123251
1 2 3 2 5 1
INSIDE TOP FLAP PRINTING
UNVARNISHED LOT/EXP AREA
(b) (4)
DailyDose
DailyDose
DailyDose
DailyDose
DailyDose
Each 5 Day Card containsten 4 mg capsules
NDC 62856-708-05
Rx onlyNDC 62856-708-05
Rx only
8 mg daily dose
LENV
IMA
(le
nvat
inib
) cap
sule
s
NDC
628
56-7
08-0
5®
2039
77
8 mg daily doseTake both capsules at the same time daily
Take both capsules at the same time daily
Take both capsules at the same time daily
Take both capsules at the same time daily
Take both capsules at the same time daily
Each daily dose consists of 2 capsules: two 4 mg capsules (total dose 8 mg). Each capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: two 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
Record StartDate
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
4 mg4 mg
4 mg4 mg
®
®
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
Take two 4 mg capsules once daily
1232
42
(b) (4)
DailyDose
DailyDose
DailyDose
DailyDose
DailyDose
Record StartDate
___________
Each 5 Day Card containsfive 4 mg capsules
NDC 62856-704-05
Rx onlyNDC 62856-704-05
Rx only
LENV
IMA
(le
nvat
inib
) cap
sule
s
NDC
628
56-7
04-0
5®
4 mg daily dose
2039
75
Take one capsule at the same time daily
Take one capsule at the same time daily
Take one capsule at the same time daily
Take one capsule at the same time daily
Take one capsule at the same time daily
4 mg daily dose
Each daily dose consists of 1 capsule: one 4 mg capsule (total dose 4 mg). Each capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinibmesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
4 mg4 mg
Take one 4 mg capsule once daily
®®
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
1232
46
(b) (4)
DailyDose
DailyDose
DailyDose
DailyDose
DailyDose
Record StartDate
___________
Each 5 Day Card containsfive 10 mg capsules
NDC 62856-710-05
Rx onlyNDC 62856-710-05
Rx only
LENV
IMA
(le
nvat
inib
) cap
sule
s
NDC
628
56-7
10-0
5®
10 mg daily dose
2039
73
Take one capsule at the same time daily
Take one capsule at the same time daily
Take one capsule at the same time daily
Take one capsule at the same time daily
Take one capsule at the same time daily
10 mg daily dose
10 mg10 mg
Each daily dose consists of 1 capsule: one 10 mg capsule (total dose 10 mg). Each capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinibmesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: one 10 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.Take one 10 mg capsule once daily
®®
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
1232
36
(b) (4)
4 mg4 mg
4 mg4 mg
4 mg4 mgNDC 62856-712-05
Rx onlyNDC 62856-712-05
Rx only
DailyDose
DailyDose
DailyDose
DailyDose
DailyDose
12 mg daily dose
LENV
IMA
(le
nvat
inib
) cap
sule
s
NDC
628
56-7
12-0
5®
2039
69
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Record StartDate
Each 5 Day Card containsfifteen 4 mg capsules
®12 mg daily dose
Each daily dose consists of 3 capsules: three 4 mg capsules (total dose 12 mg). Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: three 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
®
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
Take three 4 mg capsules once daily
1232
48
(b) (4)
DailyDose
DailyDose
DailyDose
DailyDose
DailyDose
Each 5 Day Card containsfive 10 mg capsules
and five 4 mg capsules
NDC 62856-714-05
Rx onlyNDC 62856-714-05
Rx only
14 mg daily dose
LENV
IMA
(le
nvat
inib
) cap
sule
s
NDC
628
56-7
14-0
5®
2039
71
14 mg daily doseTake both capsules at the same time daily
Take both capsules at the same time daily
Take both capsules at the same time daily
Take both capsules at the same time daily
Take both capsules at the same time daily
Each daily dose consists of 2 capsules: one 10 mg capsule and one 4 mg capsule (total dose 14 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: one 10 mg capsule and one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
Record StartDate
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
4 mg10 mg10 mg 4 mg
®
®
Take one 10 mg capsule and one4 mg capsule together once daily
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
1232
44
(b) (4)
NDC 62856-718-05
Rx onlyNDC 62856-718-05
Rx only
DailyDose
DailyDose
DailyDose
DailyDose
DailyDose
18 mg daily dose
LENV
IMA
(le
nvat
inib
) cap
sule
s
NDC
628
56-7
18-0
5®
2039
67
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Record StartDate
_
Each 5 Day Card containsfive 10 mg capsules
and ten 4 mg capsules
4 mg10 mg10 mg 4 mg
4 mg4 mg
®
Each daily dose consists of 3 capsules: one 10 mg capsule and two 4 mg capsules (total dose 18 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinibequivalent to 4.90 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: one 10 mg capsule and two 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
18 mg daily dose
®
Take one 10 mg capsule and two4 mg capsules together once daily
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
1232
44
(b) (4)
DailyDose
DailyDose
DailyDose
DailyDose
DailyDose
20 mg daily dose
Record StartDate
___________
Each 5 Day Card containsten 10 mg capsules
NDC 62856-720-05
Rx onlyNDC 62856-720-05
Rx only
LENV
IMA
(le
nvat
inib
) cap
sule
s
NDC
628
56-7
20-0
5®
2039
63
20 mg daily dose
Take both capsules at the same time daily
Take both capsules at the same time daily
Take both capsules at the same time daily
Take both capsules at the same time daily
Take both capsules at the same time daily
Each daily dose consists of 2 capsules: two 10 mg capsules (total dose 20 mg). Each capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: two 10 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
10 mg10 mg
10 mg10 mg
®
®
Take two 10 mg capsules once daily
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
1232
40
(b) (4)
NDC 62856-724-05
Rx onlyNDC 62856-724-05
Rx only
DailyDose
DailyDose
DailyDose
DailyDose
DailyDose
24 mg daily dose
LENV
IMA
(le
nvat
inib
) cap
sule
s
NDC
628
56-7
24-0
5®
2039
65
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Take all three capsules at the same time daily
Record StartDate
Each 5 Day Card containsten 10 mg capsules
and five 4 mg capsules
4 mg10 mg 10 mg10 mg10 mg 4 mg
®24 mg daily dose
Each daily dose consists of 3 capsules: two 10 mg capsules and one 4 mg capsule (total dose 24 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.
See package insert for dosage information.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dosing Instructions:Take one daily dose: two 10 mg capsules and one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.
P
PUSH
PUSH
Push through blackhalf circle.
1. Turn card over andpeel tab to exposefoil.
2. Turn card over and pushon END of plastic blisterto dispense.
3.
®
Take two 10 mg capsules and one4 mg capsule together once daily
Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan
1232
50
(b) (4)
Ramesh Digitally signed by Ramesh Raghavachari Date: 4/23/2020 02:05:02PMRaghavachari GUID: 502d0913000029f375128b0de8c50020
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