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Asenapine (Saphris, Secuado): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
10 mg, 5 mg, 2.5 mg
Brand names:
Active ingredient:

Patient information: uses, side effects, how to take - Asenapine

INSTRUCTIONS FOR USE Asenapine Sublingual Tablets

Read these Instructions for Use before you start using asenapine sublingual tablets 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 Tablets:

Step 1. Hold the blister as such that it faces the printed blister foil side and tear along the perforation marked on the blister to separate.

Figure A

Step 2. Peel the paper where "PEEL & PUSH" is given on the blister to expose foil.

Figure B

Step 3. Gently PUSH tablet through foil and take the tablet (see Figure C). Do not split, cut or crush the tablet.

Figure C

Step 4. Place the whole tablet under tongue and allow it to dissolve completely (see Figure D).

Figure D

Do not chew or swallow the tablet.

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

Figure E

Storing asenapine sublingual tablets:

Store asenapine sublingual tablets at room temperature between 68°F to 77°F (20°C to 25°C).

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

Manufactured by:

MSN Laboratories Private Limited

Telangana- 509 228, INDIA.

Distributed by:

Breckenridge Pharmaceutical, Inc.

Berlin, CT 06037

Revised: 08/2021

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 205960 · View the label on DailyMed

Revision date stated in the text: August 2021

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Asenapine

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Atypical Antipsychotic
Active ingredient Asenapine maleate
Dosage form Tablet
Route Sublingual
Marketing status listed in the FDA NDC Directory
Company (applicant) BRECKENRIDGE
FDA approval ANDA 205960Abbreviated New Drug Application (ANDA) – generic drug Approved December 10, 2020
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Saphris with the same TE code
Manufacturers 5 labelers list this drug on DailyMed
Packages (NDC)
Package
10 mg – 60 in 1 box NDC 69539-059-34
10 mg – 60 in 1 box NDC 69539-060-34
5 mg – 60 in 1 box NDC 69539-057-34
5 mg – 60 in 1 box NDC 69539-058-34
2.5 mg – 60 in 1 box NDC 69539-245-34

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.