Qsymia (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 7.5 mg/46 mg Capsule Bottle Label

NDC NUMBER 62541-202-30

Qsymia ^®
(phentermine and topiramate extended-release) capsules CIV

7.5 mg/46 mg

30 Capsules

Rx only

DISPENSE WITH MEDICATION GUIDE

PRINCIPAL DISPLAY PANEL — 3.75 mg/23 mg Capsule Bottle Label

NDC NUMBER 62541-201-30

Qsymia ^®
(phentermine and topiramate extended-release) capsules CIV

3.75 mg/23 mg

30 Capsules

Rx only

DISPENSE WITH MEDICATION GUIDE

PRINCIPAL DISPLAY PANEL — 15 mg/92 mg Capsule Bottle Label

NDC NUMBER 62541-204-30

Qsymia ^®
(phentermine and topiramate extended-release) capsules CIV

15 mg/92 mg

30 Capsules

Rx only

DISPENSE WITH MEDICATION GUIDE

PRINCIPAL DISPLAY PANEL — 11.25 mg/69 mg Capsule Bottle Label

NDC NUMBER 62541-203-30

Qsymia ^®
(phentermine and topiramate extended-release) capsules CIV

11.25 mg/69 mg

30 Capsules

Rx only

DISPENSE WITH MEDICATION GUIDE

QSYMIA phentermine and topiramate capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-202 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE 7.5 mg TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 46 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE ETHYLCELLULOSE, UNSPECIFIED POVIDONE K30 GELATIN, UNSPECIFIED TALC TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 3 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 SUCROSE STARCH, CORN

Product Characteristics Color purple, yellow Score no score Shape CAPSULE Size 12mm Flavor Imprint Code VIVUS;75;46 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62541-202-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022580 09/17/2012

QSYMIA phentermine and topiramate capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-201 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE 3.75 mg TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 23 mg

Inactive Ingredients Ingredient Name Strength SUCROSE STARCH, CORN MICROCRYSTALLINE CELLULOSE ETHYLCELLULOSE, UNSPECIFIED POVIDONE K30 GELATIN, UNSPECIFIED TALC TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 3

Product Characteristics Color purple Score no score Shape CAPSULE Size 12mm Flavor Imprint Code VIVUS;375;23 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62541-201-14 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE None 2 NDC:62541-201-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022580 09/17/2012

QSYMIA phentermine and topiramate capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-204 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE 15 mg TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 92 mg

Inactive Ingredients Ingredient Name Strength SUCROSE STARCH, CORN MICROCRYSTALLINE CELLULOSE ETHYLCELLULOSE, UNSPECIFIED POVIDONE K30 GELATIN, UNSPECIFIED TALC TITANIUM DIOXIDE FD&C YELLOW NO. 5 FD&C YELLOW NO. 6

Product Characteristics Color yellow, white Score no score Shape CAPSULE Size 12mm Flavor Imprint Code VIVUS;15;92 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62541-204-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022580 09/17/2012

QSYMIA phentermine and topiramate capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62541-203 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE 11.25 mg TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 69 mg

Inactive Ingredients Ingredient Name Strength SUCROSE STARCH, CORN MICROCRYSTALLINE CELLULOSE ETHYLCELLULOSE, UNSPECIFIED POVIDONE K30 GELATIN, UNSPECIFIED TALC TITANIUM DIOXIDE FD&C YELLOW NO. 5 FD&C YELLOW NO. 6

Product Characteristics Color yellow Score no score Shape CAPSULE Size 12mm Flavor Imprint Code VIVUS;1125;69 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62541-203-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022580 09/17/2012

Labeler — Vivus LLC (782772263)

Revised: 04/2022 Vivus LLC