Tapentadol Hydrochloride Solution
Product Images NDC 70954-801

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Tapentadol Hydrochloride (NDC 70954-801). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ani Pharmaceuticals, 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

Carton-1 (Carton 1)

Packaging label for Tapentadol Hydrochloride Oral Solution 20 mg/mL by ANI Pharmaceuticals, Inc. The label includes dosage strength, volume of 100 mL, usage instructions to dispense with an appropriately graduated oral syringe, and storage conditions. The label also states the product is for oral use and prescription only, with distribution information and a barcode present.*

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Carton-2 (Carton 2)

Packaging label for Tapentadol Hydrochloride Oral Solution 20 mg/mL by ANI Pharmaceuticals, Inc. The label states each 1 mL contains 20 mg tapentadol in solution and includes a 200 mL bottle. It also mentions the package contains one bottle, an oral syringe for adult dosing with adapter, and patient instructions. Storage instructions specify 20°C to 25°C with permitted excursions to 15°C to 30°C, and to keep the bottle upright after opening and out of reach of children.*

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Figure-1 (Figure 1)

A line graph showing the relationship between percent improvement in pain from baseline at hour 48 (x-axis) and percent of patients improved (y-axis). It compares placebo with Tapentadol Hydrochloride at doses of 50 mg, 75 mg, and 100 mg, illustrating patient response rates across these doses over the pain improvement scale.*

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Figure-2 (Figure 2)

A line graph showing percent improvement in pain from baseline on day 5 along the x-axis and percent of patients improved along the y-axis. It compares three groups: Placebo, Tapentadol Hydrochloride 50 mg, and Tapentadol Hydrochloride 75 mg, with the latter two showing higher improvement percentages than placebo over the range of improvement percentages.*

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Figure-a (Figure A)

An instructional diagram showing components for oral administration of medication, including a bottle, an adapter, and an oral syringe with labeled parts: barrel and plunger, and volume markings at 5 mL, 15 mL, and 25 mL.*

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Fig-b (Figure B)

An instructional illustration showing how to open a child-resistant cap on a bottle. One hand grips and holds the bottle while the other hand pushes down and turns the cap to the side. Next to it, another image shows the cap removed from the bottle with fingers lifting it off.*

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Fig-c (Figure C)

An instructional illustration showing a person gripping a bottle with both hands on a table, focusing on the ribbed end of the bottle cap. The inset highlights the ribbed texture on the cap, indicating where to hold or twist. This likely demonstrates how to properly open the bottle.*

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Fig-d (Figure D)

Illustration of an oral syringe used for administering liquid medication. The syringe is marked with volume measurements up to 2 mL for precise dosing. The design includes a plunger and a narrow tip suitable for oral use.*

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Fig-e (Figure E)

An instructional illustration labeled Figure E showing a hand pressing down on the plunger of a syringe-like device, with the other hand stabilizing the object. A downward arrow indicates the direction of the pressing action.*

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Fig-f (Figure F)

An instructional illustration showing a hand using an oral dosing syringe to withdraw liquid medication from a bottle. The syringe is inserted into the bottle's neck while another hand holds the bottle steady, demonstrating proper technique for measuring and administering oral solution.*

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Fig-h (Figure H)

An instructional illustration labeled Figure H showing hands using an oral syringe to measure liquid medication from a bottle. The image demonstrates how to draw up the solution by withdrawing the syringe plunger while the bottle is inverted.*

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Fig-i (Figure I)

An instructional illustration showing a hand holding a bottle while drawing liquid into a syringe from the bottle. The bottle is placed on a flat surface, and an upward arrow indicates the direction of syringe removal. Labeled as Figure I.*

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Fig-j (Figure J)

An illustration of an oral syringe marked with measurement graduations at 2.5 mL, 3.75 mL, and 5 mL. The syringe is designed for accurate dosing of liquid medication.*

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Fig-k (Figure K)

An instructional line drawing labeled Figure K showing a person using an oral syringe for medication administration. The syringe is positioned near the person's mouth, indicating the oral route of administration.*

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Fig-m (Figure M)

An instructional illustration demonstrating a hand gripping the body of an oral solution bottle and using the other hand to twist the cap counterclockwise to open it. The image is labeled as Figure M.*

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Label-1 (Label 1)

Tapentadol Hydrochloride Oral Solution 20 mg/mL label displaying drug concentration and dosage form. The label includes dosing guidance, storage instructions specifying 20°C to 25°C with permitted excursions, and a pharmacist warning to dispense with an appropriate oral syringe. The 100 mL container is distributed by ANI Pharmaceuticals, Inc., with a lot number, expiration date, serial number, and barcode visible.*

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Label-2 (Label 2)

Label for Tapentadol Hydrochloride Oral Solution 20 mg/mL by ANI Pharmaceuticals, Inc. The label instructs dispensing a graduated oral syringe for dosage accuracy. It indicates a 200 mL bottle size and storage conditions between 20°C to 25°C with permitted excursions. The label includes barcodes, lot number, expiration date, and distributor information.*

FDA Label Image

Structure (Structure)

Chemical structure of Tapentadol Hydrochloride, depicting the molecular arrangement including a phenol group, amine, and hydrochloride component as part of the compound.*

* 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.