Tosymra
Product Images NDC 67857-812

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Tosymra (NDC 67857-812). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Promius Pharma, Llc., 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

Blister Lidding Artwork (Blister Lidding Artwork)

Label for TOSYMRA (sumatriptan nasal spray) 10 mg, Rx only. Each unit dose contains 10 mg sumatriptan in 0.1 mL, single spray per unit, for intranasal use only. Label includes storage instructions, warnings, manufacturer (Dr. Reddy's Laboratories Limited), and distributor (Promius Pharma, LLC). Contains barcodes and peel-off instruction.*

FDA Label Image

Carton Artwork (Carton Artwork)

The unfolded packaging label for TOSYMRA (sumatriptan nasal spray) 10 mg by Promius Pharma, LLC. The box design includes the brand name with a floral pattern, dosage form, and strength prominently displayed. It indicates the product contains six unit dose nasal spray devices, with usual usage and storage instructions, and emphasizes prescription-only status. Barcodes and regulatory information appear along the sides.*

FDA Label Image

Fig-a (Figurea)

An instructional illustration labeled Figure A showing parts of a nasal spray device. The diagram identifies the Tip (Nose) at the top, the Spray Nozzle along the side, and the Plunger (Thumb) at the bottom center, indicating how to hold and operate the spray.*

FDA Label Image

Fig-b (Figureb)

An instructional illustration labeled Figure B showing two hands applying or pressing a folded cloth or pad against the lower part of a face, focusing on the area below the nose and above the upper lip.*

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Fig-c (Figurec)

An illustration showing a hand removing a single blister pack device from a box containing multiple such devices arranged vertically. The text above the hand instructs to "Remove Only 1 Device." The image is labeled as Figure C and appears to be part of usage or packaging instructions for TOSYMRA by Promius Pharma, LLC.*

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Fig-d (Figured)

An instructional illustration showing a hand holding a card with text displaying 'LOT XXXXXX EXP MMYY' positioned next to an eye, with an arrow indicating that the eye is directed towards the card. The figure is labeled as 'Figure D'.*

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Fig-e (Figuree)

An instructional diagram showing how to remove and prepare a device from its packaging. The image shows hands flipping over a blister pack and placing the device on a palm, depicting steps needed to access and hold the product, labeled as Figure E.*

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Fig-f (Figuref)

An instructional diagram labeled 'Figure F' showing how to observe the lot number and expiration date on a device. The image depicts a side view of an eye looking at a specific section of the device where the lot number and expiration date are printed.*

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Fig-g (Figureg)

An instructional illustration labeled Figure G showing a person holding their index finger vertically against the side of their nose, below the eye level. The image focuses on the lower half of the face and hand.*

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Fig-h-i (Figurehi)

An instructional illustration showing hand positioning for using a nasal spray device. Figure H depicts a hand holding the device with a thumb pressing the bottom. Figure I shows the device being inserted into a nostril angled outward, indicated by a directional arrow.*

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Fig-j (Figurej)

An instructional illustration showing a person administering nasal spray. It depicts the head tilted back slightly with arrows indicating the motion. The figure highlights proper head positioning for use of the nasal spray, labeled as Figure J.*

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Fig-k (Figurek)

Instructional illustration for TOSYMRA nasal spray by Promius Pharma, LLC. It shows a hand pressing the plunger up on the device and another image demonstrating inhaling through the nostril to use the spray properly.*

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Fig-l (Figurel)

An instructional illustration showing a person exhaling through the mouth with airflow arrows. A clock face indicates a duration of 10 to 20 seconds. Text instructs to gently breathe in through the nose and out through the mouth, labeled as Figure L.*

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Fig-m (Figurem)

An instructional illustration showing a hand disposing of a small item into a container labeled 'Household Trash.' The diagram is labeled as Figure M, indicating it is part of a sequence demonstrating proper disposal instructions.*

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Table 1 (Table 1)

Table displaying adverse reactions in pooled placebo-controlled trials for sumatriptan injection 6 mg subcutaneous versus placebo in migraine patients. It lists various adverse reactions by category, showing their incidence percentages in both treatment and placebo groups based on patient counts (547 for sumatriptan, 370 for placebo).*

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Table 2 (Table 2)

A data table showing the proportion of patients with migraine relief and incidence of adverse reactions by dose of sumatriptan injection over different time points (10 minutes, 30 minutes, 1 hour, and 2 hours) in Study 1. It compares placebo and doses from 1 mg to 8 mg, with respective percentages for relief and adverse reaction incidence. A footnote highlights efficacy of Tosymra nasal spray at 4 mg dose compared to sumatriptan SC injection.*

FDA Label Image

Table 3 (Table 3)

Data table summarizing the proportion of patients experiencing pain relief and relief of migraine symptoms at 1 and 2 hours after treatment in two clinical studies (Study 2 and Study 3). It compares placebo and sumatriptan injection 6 mg groups on outcomes including pain relief, absence of pain, absence of nausea, absence of photophobia, and clinical disability.*

FDA Label Image

Structure (Structure)

Chemical structure of the active ingredient in TOSYMRA by Promius Pharma, LLC. The diagram shows a molecular structure with sulfur, oxygen, nitrogen, and carbon atoms arranged in a complex ring and chain formation representing the drug's chemical makeup.*

* 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.