Memantine Hydrochloride Solution
Product Images NDC 13925-540

14 FDA label images from Seton Pharmaceuticals · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Memantine Hydrochloride (NDC 13925-540). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Seton Pharmaceuticals, 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

Figure 1 Memantine (Figure 1 Memantine)

Figure 1 Memantine (Figure 1 Memantine)
A line graph depicting mean change from baseline in ADCS-ADL score over 28 weeks of treatment comparing Memantine and Placebo. The vertical axis shows the mean change with SEM, indicating clinical improvement or decline, while the horizontal axis represents weeks of treatment at 0, 4, 12, and 28 weeks. Memantine maintains closer to baseline scores, whereas Placebo shows a decline over time.*
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Figure 2 Memantine (Figure 2 Memantine)

Figure 2 Memantine (Figure 2 Memantine)
A cumulative percentage plot comparing patients receiving Memantine versus placebo, depicting changes from baseline in ADCS-ADL scores. The horizontal axis shows ADCS-ADL change from baseline, while the vertical axis shows cumulative patient percentage. Memantine shows a higher cumulative percentage across most score changes compared to placebo.*
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Figure 3 Memantine (Figure 3 Memantine)

Figure 3 Memantine (Figure 3 Memantine)
Line graph showing mean change from baseline in SIB score over 28 weeks of treatment comparing Memantine and placebo. The y-axis represents mean ± SEM change, with clinical improvement and decline marked. Memantine maintains higher scores over time while placebo shows decline.*
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Figure 4 Memantine (Figure 4 Memantine)

Figure 4 Memantine (Figure 4 Memantine)
A line graph depicting the cumulative percentage of patients versus SIB (Severe Impairment Battery) change from baseline. It compares two groups: placebo and memantine, showing the progression of patient responses over the specified SIB change range.*
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Figure 5 Memantine (Figure 5 Memantine)

Figure 5 Memantine (Figure 5 Memantine)
Line graph comparing the mean change from baseline in ADCS-ADL scores over 24 weeks of treatment between Placebo/Donepezil and Memantine/Donepezil groups. The x-axis represents weeks of treatment (0 to 24), and the y-axis shows mean changes in scores, indicating clinical improvement or decline. Data points with error bars are shown for each group throughout the treatment period.*
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Figure 6 Memantine (Figure 6 Memantine)

Figure 6 Memantine (Figure 6 Memantine)
A line graph comparing the cumulative percentage of patients versus ADCS-ADL change from baseline for two groups: Placebo/Donepezil and Memantine/Donepezil. The x-axis shows the ADCS-ADL change from baseline, and the y-axis shows the cumulative percentage of patients, illustrating treatment response differences over a range.*
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Figure 7 Memantine (Figure 7 Memantine)

Figure 7 Memantine (Figure 7 Memantine)
Line graph showing mean (± SEM) change from baseline in SIS score over 24 weeks of treatment comparing Placebo/Donepezil and Memantine/Donepezil. The x-axis represents weeks of treatment, and the y-axis measures change in SIS score, with positive values indicating clinical improvement and negative values indicating clinical decline. Memantine/Donepezil group shows clinical improvement, while Placebo/Donepezil shows clinical decline over time.*
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Figure 8 Memantine (Figure 8 Memantine)

Figure 8 Memantine (Figure 8 Memantine)
A line graph comparing cumulative percentage of patients versus SIB (Severe Impairment Battery) change from baseline for two treatment groups: Placebo/Donepezil and Memantine/Donepezil. The graph shows progression in patient response across a range of SIB score changes with distinct curves for each group.*
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Memantine Instructions (Instructions)

Memantine Instructions (Instructions)
Instructional diagram illustrating how to use Memantine Hydrochloride Oral Solution 2 mg/mL. Steps show removing the dosing syringe and plastic adaptor from packaging, opening and preparing the bottle by removing the cap and seal, inserting the adaptor and syringe, measuring and administering the dose orally, replacing the child-resistant cap, rinsing the syringe, and storing the bottle upright. Includes visual guidance for each step with line drawings and photos.*
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Memantine Bottle (Memantine Bottle)

Memantine Bottle (Memantine Bottle)
Memantine Hydrochloride Oral Solution 2 mg/mL packaging and contents by Seton Pharmaceuticals. The image shows a 12 fl oz (360 mL) amber bottle with a white cap, labeled with the product name and strength, accompanied by its white and gray carton box displaying similar information. Included are a dosing cup, an oral syringe sealed in a plastic pouch, and a barcode label, all arranged on a plain background.*
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Table 1 (Table 1)

Table 1 (Table 1)
A data table comparing adverse reaction percentages between placebo (N=922) and Memantine Hydrochloride (N=940). It lists reactions across body systems including body as a whole, cardiovascular, central and peripheral nervous, gastrointestinal, musculoskeletal, psychiatric, and respiratory systems, showing incidence rates for symptoms such as fatigue, headache, dizziness, constipation, confusion, coughing, and others.*
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Dosing-titration-schedule (Dosing Titration Schedule)

Dosing-titration-schedule (Dosing Titration Schedule)
A table showing the dosing schedule for Memantine Hydrochloride Oral Solution, 2 mg/mL, detailing total daily doses and strength per dose in milligrams from starting dose through the third week.*
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Label (Label)

Label (Label)
Memantine Hydrochloride Oral Solution 2 mg/mL label showing the product name, dosage strength, and form as a liquid solution. The label includes storage instructions, dosage reference, and warnings about tamper-evidence and child safety. Manufactured by Medley Pharmaceuticals Ltd. and Seton Pharmaceuticals, with contact details and issuance date 02/21. The label also features a barcode and Seton Pharmaceuticals logo.*
FDA Label Image

Memantine-structure (Memantine Structure)

Memantine-structure (Memantine Structure)
Chemical structure of Memantine Hydrochloride, an active ingredient in Memantine Hydrochloride Oral Solution 2 mg/mL by Seton Pharmaceuticals.*

* 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.