ASENAPINE (Page 8 of 8)

INSTRUCTIONS FOR USE

ASENAPINE

SUBLINGUAL TABLETS

Read these Instructions for Use before you start using Asenapine sublingual tablet(s) and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment.

IMPORTANT:

• For sublingual (under your tongue) use only
• Do not remove tablet until ready to administer.
• Use dry hands when handling tablet.

Directions for taking your Asenapine sublingual tablet(s):

Step 1: Gently remove the tablet from the bottle. Do not split, cut or crush the tablet.

Step 2: Place the whole tablet under tongue and allow it to dissolve completely (see Figure A).

Figure A

Do not chew or swallow the tablet.

Do not eat or drink for 10 minutes (See Figure B).

Figure B

Storing Asenapine sublingual tablet(s):

Store Asenapine sublingual tablet(s) at room temperature between 68°F to 77°F (20°C to 25°C), in the container it comes in.

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

Sigmapharm Laboratories, LLC

Bensalem, PA 19020

OS017-11 REV.1220

Revised: December 2020

PRINCIPAL DISPLAY PANEL — 5 MG 10 COUNT CONTAINER LABEL

Prinicipal Display Panel — 5 mg 10 count Container Label

NDC 42794- 016 -22

Asenapine Sublingual Tablets

5 mg

Do not split, cut or crush tablet. Do not chew or swallow tablet.

DISPENSE ONLY IN ORIGINAL CONTAINER.

Black Cherry

Flavor

Rx only

10 Tablets

PRINCIPAL DISPLAY PANEL — 5 MG 30 COUNT CONTAINER LABEL

Prinicipal Display Panel — 5 mg 30 count Container Label

NDC 42794- 016 -18

Asenapine Sublingual Tablets

5 mg

Do not split, cut or crush tablet. Do not chew or swallow tablet.

DISPENSE ONLY IN ORIGINAL CONTAINER.

Black Cherry

Flavor

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL — 5 MG 60 COUNT CONTAINER LABEL

Prinicipal Display Panel — 5 mg 60 count Container Label

NDC 42794- 016 -10

Asenapine Sublingual Tablets

5 mg

Do not split, cut or crush tablet. Do not chew or swallow tablet.

DISPENSE ONLY IN ORIGINAL CONTAINER.

Black Cherry

Flavor

Rx only

60 Tablets

PRINCIPAL DISPLAY PANEL — 10 MG 10 COUNT CONTAINER LABEL

Prinicipal Display Panel — 10 mg 10 count Container Label

NDC 42794- 017 -22

Asenapine Sublingual Tablets

10 mg

Do not split, cut or crush tablet. Do not chew or swallow tablet.

DISPENSE ONLY IN ORIGINAL CONTAINER.

Black Cherry

Flavor

Rx only

10 Tablets

PRINCIPAL DISPLAY PANEL — 10 MG 30 COUNT CONTAINER LABEL

Prinicipal Display Panel — 10 mg 30 count Container Label

NDC 42794- 017 -08

Asenapine Sublingual Tablets

10 mg

Do not split, cut or crush tablet. Do not chew or swallow tablet.

DISPENSE ONLY IN ORIGINAL CONTAINER.

Black Cherry

Flavor

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL — 10 MG 60 COUNT CONTAINER LABEL

Prinicipal Display Panel — 10 mg 60 count Container Label

NDC 42794- 017 -10

Asenapine Sublingual Tablets

10 mg

Do not split, cut or crush tablet. Do not chew or swallow tablet.

DISPENSE ONLY IN ORIGINAL CONTAINER.

Black Cherry

Flavor

Rx only

60 Tablets

ASENAPINE asenapine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42794-016 Route of Administration SUBLINGUAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASENAPINE (ASENAPINE) ASENAPINE 5 mg

Inactive Ingredients Ingredient Name Strength COPOVIDONE CROSPOVIDONE POLYOXYL 35 CASTOR OIL MANNITOL MAGNESIUM STEARATE ANHYDROUS CITRIC ACID BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE SODIUM BICARBONATE MALTODEXTRIN PROPYLENE GLYCOL TRIETHYL CITRATE

Product Characteristics Color white Score no score Shape ROUND (Round, FFBE) Size 8mm Flavor CHERRY (Black Cherry) Imprint Code 16 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42794-016-22 10 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:42794-016-08 30 TABLET in 1 BOTTLE, PLASTIC None 3 NDC:42794-016-10 60 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206107 12/14/2020

ASENAPINE asenapine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42794-017 Route of Administration SUBLINGUAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASENAPINE (ASENAPINE) ASENAPINE 10 mg

Inactive Ingredients Ingredient Name Strength COPOVIDONE CROSPOVIDONE POLYOXYL 35 CASTOR OIL MANNITOL MAGNESIUM STEARATE ANHYDROUS CITRIC ACID BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE SODIUM BICARBONATE MALTODEXTRIN PROPYLENE GLYCOL TRIETHYL CITRATE

Product Characteristics Color white Score no score Shape ROUND (Round, FFBE) Size 10mm Flavor CHERRY (Black Cherry) Imprint Code 17 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42794-017-22 10 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:42794-017-08 30 TABLET in 1 BOTTLE, PLASTIC None 3 NDC:42794-017-10 60 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206107 12/14/2020

Labeler — Sigmapharm Laboratories, LLC (556234636)

Establishment
Name	Address	ID/FEI	Operations
Sigmapharm Laboratories		556234636	manufacture (42794-016), manufacture (42794-017), analysis (42794-016), analysis (42794-017)

Revised: 01/2023 Sigmapharm Laboratories, LLC