Saphris 01
Chemical structure of Asenapine Maleate, illustrating the molecular diagram of the active ingredient used in SAPHRIS tablets.*
Saphris Tablet
Product Images NDC 0456-2410
17 FDA label images from Allergan, Inc. · Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Saphris (NDC 0456-2410). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Allergan, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Saphris 02
A forest plot chart showing fold changes with 90% confidence intervals in pharmacokinetic parameters Cmax and AUC of SAPHRIS (Asenapine Maleate) when co-administered with various CYP inhibitors and inducers including Fluvoxamine, Imipramine, Paroxetine, Cimetidine, Carbamazepine, and Valproate. The horizontal axis represents change relative to reference from 0.5 to 2.0, indicating increases or decreases in drug exposure.*
Saphris 03
A forest plot chart illustrating the fold change and 90% confidence interval (CI) for pharmacokinetic parameters (Cmax and AUC) of substrates and inhibitors (Paroxetine, Imipramine, Desipramine) when co-administered with Asenapine Maleate. The x-axis represents the change relative to the reference from 0.5 to 2.5 fold, showing the effects on metabolism pathways CYP2D6, CYP1A2/2C19/3A4, and CYP2C19/2D6.*
Saphris 04
A pharmacokinetic (PK) graph showing fold change and 90% confidence intervals for Cmax and AUC in various populations including renal impaired (mild to severe), hepatic impaired (mild to severe), smokers, Japanese, and pediatric subjects relative to reference groups. The data illustrate relative changes in drug exposure parameters for these groups.*
Saphris 05
A Kaplan-Meier survival curve graph depicting relapse rates over time in days for SAPHRIS (asenapine maleate) compared to placebo. The solid line represents SAPHRIS, and the dotted line represents placebo. The graph includes a table of patients at risk at various time points.*
Saphris 06
A line graph comparing SAPHRIS and placebo treatments over time in days, showing percentage outcomes on the vertical axis from 0 to 100%. The graph features a solid line for SAPHRIS and a dashed line for placebo, with the placebo line consistently higher than SAPHRIS over the period of up to 240 days. Numbers at risk for each group are displayed beneath the x-axis across the time points.*
Saphris 07
An instructional illustration showing a tablet pack inside a case designed for SAPHRIS tablets. The image highlights a thumb button used to open the case, with labeled parts including the tablet pack, case, and thumb button for easy identification.*
Saphris 08
An instructional diagram showing how to open a tablet pack from a case featuring a thumb button. The labeled parts include the tablet pack being pulled out, the case holding the pack, and the thumb button used to release the pack. Likely related to a medication packaging system for ease of use.*
Saphris 09
An instructional illustration showing a hand holding a blister pack with a colored tab labeled as 'Tablet Pocket Colored Tab,' demonstrating how to identify the tablet location within the pack.*
Saphris 0a
An instructional illustration showing two hands manipulating a tablet, demonstrating the process of removing or handling the tablet. The image likely corresponds to usage or administration directions for the SAPHRIS sublingual tablet.*
Saphris 0b
Illustration showing a person placing a sublingual tablet under their tongue, demonstrating the administration method for SAPHRIS (Asenapine Maleate) sublingual tablets.*
Saphris 0c
An instructional diagram emphasizing a 10-minute waiting period before eating or drinking. The image includes a crossed-out fork, knife, and glass of water, indicating no food or drink intake during this time. It is relevant for sublingual tablet administration instructions.*
Saphris 0d
An instructional illustration showing a person's hands opening a cardboard carton containing SAPHRIS sublingual tablets. One hand holds the carton while the other hand pulls back the top flap, guided by an arrow indicating the opening direction.*
Saphris 0e
Label for Saphris 2.5 mg sublingual tablets (asenapine) in black cherry flavor. The label states the tablets are for sublingual use, with a caution not to split, cut, crush, chew, or swallow the tablet. The package contains 10 tablets. The labeler is Allergan, Inc., with manufacturing and distribution details also provided.*
Saphris 0f
SAPHRIS 2.5 mg (asenapine) sublingual tablets packaging label displaying black cherry flavor. The label states the product contains 60 tablets and is for sublingual use only, emphasizing not to split, cut, crush, or swallow tablets. Manufacturer Allergan, Inc. is not shown, but the labeler is Allergan, Inc. Detailed administration instructions with step-by-step illustrations guide proper tablet use.*
Saphris 10
Packaging label for Saphris 5 mg (asenapine) sublingual tablets by Allergan, Inc. The box contains 60 tablets with a black cherry flavor. It is indicated for sublingual use only, with instructions to avoid splitting, cutting, crushing, or swallowing the tablet whole. The label includes storage conditions, manufacturer details, and step-by-step administration instructions with illustrations on the carton.*
Saphris 11
SAPHRIS 10 mg sublingual tablets carton label by Allergan, Inc. This packaging contains 60 black cherry flavored tablets with asenapine maleate as the active ingredient. The label highlights instructions for sublingual administration and storage information. The carton is marked Rx only and includes handling warnings not to split, cut, crush, chew, or swallow the tablet.*
* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.
