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).

asp-6

Figure A

Do not chew or swallow the tablet.

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

asp-7

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

asp-12
(click image for full-size original)

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

asp-13
(click image for full-size original)

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

asp-8
(click image for full-size original)

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

asp-14
(click image for full-size original)

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

asp-15
(click image for full-size original)

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

asp-10
(click image for full-size original)
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

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