Transmucosal Fentanyl Citrate
Product Images NDC 52959-548

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Transmucosal Fentanyl Citrate (NDC 52959-548). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by H.j. Harkins Company, 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

Otfc Unit (Fentanyl Shadow Redel)

Transmucosal Fentanyl Citrate 400 mcg oral transmucosal lozenge on a stick. The product is labeled with "FENTANYL 400" on the lozenge and "fentanyl 400 mcg" on the handle. The labeler is H.J. Harkins Company, Inc.*

FDA Label Image

400 mg (Labela)

Label for Transmucosal Fentanyl Citrate Oral 400 mcg lozenge by H.J. Harkins Company, Inc., with lot number FYC01UT and expiration date 10/11. The label includes manufacturer details (ANESTACORP, Salt Lake City, Utah), a pill ID noted as lozenge, dosage instructions, and multiple small labels showing the product name, strength, lot, quantity (#30), and NDC 55253-071-30.*

FDA Label Image

600 mg (Labelb)

Label for Transmucosal Fentanyl Citrate Oral 600 mcg lozenges by H.J. Harkins Company, Inc. The label includes lot number, manufacturer AnestaCorp in Salt Lake City, Utah, expiration date 09/11, and comparison to Actiq Oral. The packaging shows dosage instructions and multiple barcodes.*

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1200 mg (Labelc)

Packaging label for Transmucosal Fentanyl Citrate Oral 1200 mcg lozenges by H.J. Harkins Company, Inc. The label includes the lot number FYL00UT, expiration date 08/11, and manufacturer details. It also contains dosage instructions advising to follow a doctor's direction and features multiple smaller package labels. The label highlights this is a prescription-only medication with cautionary storage and legal information.*

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Structural Formula (Otfc 01)

Chemical structure of Transmucosal Fentanyl Citrate depicting its molecular arrangement with labeled chemical groups and bonds.*

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Figure 1. Mean Serum Fentanyl Concentration (ng/ml) In Adult Subjects Comparing 4 Doses Of Otfc (Otfc 02)

A line graph showing mean serum fentanyl concentration (ng/mL) over time in minutes for Transmucosal Fentanyl Citrate at doses of 200 mcg, 400 mcg, 800 mcg, and 1600 mcg. Concentration decreases over time for each dose, with higher doses showing higher initial concentrations.*

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Figure 2. Pain Relief (pr) Scores (mean±sd) During The Double-blind Phase (All Patients with Evaluable Episodes on Both OTFC and Placebo (N=86))

A line graph comparing pain relief scores over 60 minutes between Transmucosal Fentanyl Citrate (OTFC) and placebo groups. The vertical axis ranges from 0 (none) to 4 (complete) pain relief. OTFC shows higher pain relief scores at measured intervals (15, 30, 45, 60 minutes) with statistically significant differences indicated.*

FDA Label Image

Cut Open The Package Using Scissors (Otfc 10)

An instructional line drawing showing two hands demonstrating the use of a package intended to release or dispense its contents. One hand holds the package horizontally while the other pulls a tab or strip outward from the right side of the package.*

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Place Otfc In Your Mouth Between Your Cheeks And Gums And Actively Suck On The Medicine. (Otfc 11)

An instructional line drawing showing a person placing a small round medication tablet inside their cheek, indicating administration of a transmucosal dosage form by buccal placement inside the mouth.*

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Dissolve The Medicine Under Hot Running Water (Otfc 12)

An instructional illustration showing a hand holding a small container or vial next to a sink or water faucet. The image appears to demonstrate a step in preparing or using the product, with the hand positioned as if about to rinse or fill the container.*

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Portable Locking Pouch (Otfc 13)

A black and white line drawing of a waist pouch or fanny pack with a zippered front pocket and an adjustable strap with a buckle closure.*

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Child-resistant Temporary Storage Bottle (Otfc 14)

Illustration of a vial with a stopper being pierced by a syringe needle, depicting the process of drawing medication from the vial. The vial is hexagonal and the syringe needle is inserted vertically through the stopper.*

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Information Icon (Otfc 9)

Chemical structure diagram of fentanyl citrate, the active ingredient in Transmucosal Fentanyl Citrate by H.J. Harkins Company, Inc. The diagram shows the molecular structure with atoms and bonds clearly labeled.*

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Otfc Titration Process (Otfc Titration Process)

Flowchart diagram titled 'Oral Transmucosal Fentanyl Citrate Titration Process' outlining dosing steps and decisions starting from 200 mcg with instructions on consumption, waiting periods, dose adjustments, and available strengths ranging from 200 to 1600 mcg. The diagram guides through evaluating adequate relief with one unit and either determining successful dose or increasing to next strength while limiting initial dispensing to 6 units.*

* 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.