Abstral
Product Images NDC 42747-222

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Abstral (NDC 42747-222). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Prostrakan, 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.

FDA Label Image

Abstral-01 (Abstral 01)

A flowchart illustrating the Abstral titration process starting with an initial 100 mcg dose. It guides through assessing adequate pain relief within 30 minutes, leading to continuing the same dose or taking a supplemental dose and increasing the dose incrementally. Included is a dosing table for subsequent episodes showing Abstral doses from 200 mcg to 800 mcg and the corresponding tablet combinations for each dose.*

FDA Label Image

Abstral-02 (Abstral 02)

Chemical structure diagram of the active ingredients in Abstral, showing molecular representations including functional groups and atomic connections consistent with the drug's formulation.*

FDA Label Image

Abstral-03 (Abstral 03)

A line graph depicting plasma concentration of fentanyl over 24 hours after administration of Abstral doses of 100, 200, 400, and 800 micrograms. The y-axis shows fentanyl plasma concentration (ng/mL) and the x-axis shows time in hours, indicating the pharmacokinetic profile with higher doses reaching greater plasma concentrations and declining over time.*

FDA Label Image

Abstral-04 (Abstral 04)

This chart compares mean pain intensity difference over time (minutes) between Abstral and placebo groups. The x-axis represents time in minutes from 0 to 60, and the y-axis shows mean pain intensity difference ranging from 0 to 4. Data points for both groups include error bars.*

FDA Label Image

Abstral-05 (Abstral 05)

Instructional illustrations showing how to open and use the Abstral sublingual tablet packaging. Figure 1 depicts a hand peeling back the foil blister to expose the tablet. Figure 2 shows the tablet being removed from the blister pack.*

FDA Label Image

Abstral-06 (Abstral 06)

Illustrations showing how to open a dose of Abstral sublingual tablet; one figure demonstrates pulling the dose strip, and the other shows peeling back the foil to access the tablet inside.*

FDA Label Image

Abstral-07 (Abstral 07)

Instructional illustrations showing the proper administration of Abstral tablets. The sequence depicts a person placing the tablet on the tongue, then the tablet dissolving in the mouth, and finally the mouth after the tablet has dissolved, indicating sublingual or buccal use.*

FDA Label Image

Abstral-08 (Abstral 08)

Packaging label for Abstral sublingual tablets containing 100 mcg fentanyl base. Each package contains 32 sublingual tablets (4 tablets per card, 8 cards total). The label includes warnings about opioid therapy and instructions for sublingual administration without chewing or swallowing the tablet whole. The product is manufactured by Novartis Consumer Health Inc. for ProStrakan, Inc.*

FDA Label Image

Abstral-09 (Abstral 09)

Packaging label for Abstral 200 mcg (fentanyl) sublingual tablets by ProStrakan, Inc. The label indicates 32 sublingual tablets per package and emphasizes the strength as equivalent to 200 mcg fentanyl base. It includes usage warnings, manufacturer information, and instructions to swallow tablets whole with no chewing.*

FDA Label Image

Abstral-10 (Abstral 10)

Packaging label for Abstral sublingual tablets, containing 300 mcg of fentanyl base per tablet. The carton includes 32 tablets in 4 cards of 8 tablets each. The product is labeled as for prescription use only by ProStrakan, Inc., manufactured by Novartis Consumer Health Inc. Instructions specify sublingual administration without chewing or swallowing the tablet whole. The label includes a warning to keep out of reach of children and to use only under specific opioid therapy, noting substitution with other fentanyl products is not advised.*

FDA Label Image

Abstral-11 (Abstral 11)

Box packaging label for Abstral 400 mcg sublingual tablets containing fentanyl base. The label indicates 32 tablets per box, distributed as 4 tablets per 8 cards. Manufactured by Novartis Consumer Health Inc. and labeled for ProStrakan, Inc. Provides warnings about opioid therapy and administration instructions not to chew or swallow the tablet whole.*

FDA Label Image

Abstral-12 (Abstral 12)

Packaging label for Abstral 600 mcg (fentanyl) sublingual tablets by ProStrakan, Inc. The label states the product contains 32 sublingual tablets (4 tablets per 8 cards) equivalent to 600 mcg fentanyl base, with directions indicating sublingual administration and warnings about opioid therapy. Manufacturer information and a pharmacy label area are also visible.*

FDA Label Image

Abstral-13 (Abstral 13)

Packaging label for Abstral 800 mcg sublingual tablets (fentanyl) by ProStrakan, Inc. The label indicates 32 tablets per pack, equivalent to 800 mcg fentanyl base, for sublingual use. It includes warnings, administration instructions, manufacturer details, and barcodes.*

* 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.