Galantamine Tablet, Film Coated
Product Images NDC 57237-049

16 FDA label images from Rising Pharma Holdings, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Galantamine (NDC 57237-049). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rising Pharma Holdings, 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

Figure 1: Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing 21 Weeks (5 Months) Of (Galantamine Fig1)

Figure 1: Time-course Of The Change From Baseline In Adas-cog Score For Patients Completing 21 Weeks (5 Months) Of (Galantamine Fig1)
A line graph depicting mean change from baseline in ADAS-cog scores over 21 weeks of treatment. The graph compares four groups: placebo, 8 mg/day, 16 mg/day, and 24 mg/day dosing. Scores show improvement or decline relative to baseline, with 8 mg/day, 16 mg/day, and 24 mg/day groups generally showing improvement while placebo shows decline.*
FDA Label Image

Galantamine Fig10

Galantamine Fig10
A line graph showing mean change from baseline in ADAS-cog score over 13 weeks of treatment comparing placebo and Galantamine 24 or 32 mg/day groups. The graph depicts improvement (negative change) for the Galantamine group and minimal change for placebo, with error bars indicating standard error.*
FDA Label Image

Galantamine Fig11

Galantamine Fig11
A cumulative percentage graph depicting ADAS-cog change from baseline for two groups: Placebo and 24 or 32 mg/day dosing. The x-axis shows ADAS-cog change values from -15 to 15, and the y-axis shows cumulative percentage of patients from 0% to 100%. The graph compares cognitive change over time between the placebo group (open circles) and the treatment group (filled diamonds), with vertical reference lines at -10, -7, -4 points, and no change (0).*
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Figure 12 (Galantamine Fig12)

Figure 12 (Galantamine Fig12)
A bar chart depicting the distribution of CIBIC-plus Rating outcomes among patients treated with Galantamine at 24 or 32 mg/day versus placebo. The x-axis shows rating categories from 'Markedly Improved' to 'Markedly Worse,' while the y-axis shows the percentage of patients for each category, comparing effectiveness between treatment and placebo groups.*
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Package Label-principal Display Panel (4 mg (60 Tablets Bottle))

Package Label-principal Display Panel (4 mg (60 Tablets Bottle))
Label for Galantamine Tablets, USP 4 mg, film-coated oral tablets. The label indicates the product contains 60 tablets and is for prescription use only. It lists the active ingredient as galantamine hydrobromide equivalent to 4 mg galantamine base per tablet. The label includes storage instructions and distributor information for Rising Health, LLC, Saddle Brook, NJ. The product is made in India by Rising Pharma Holdings, Inc.*
FDA Label Image

Package Label-principal Display Panel (8 mg (60 Tablets Bottle))

Package Label-principal Display Panel (8 mg (60 Tablets Bottle))
Label for Galantamine Tablets USP 8 mg, film-coated tablets, containing 60 tablets per package. The label indicates the drug is distributed by Rising Health, LLC and manufactured in India. Storage instructions, dosage information, and safety warnings such as keeping out of reach of children are also included, along with the NDC 57237-050-60.*
FDA Label Image

Package Label-principal Display Panel (12 mg (60 Tablets Bottle))

Package Label-principal Display Panel (12 mg (60 Tablets Bottle))
Packaging label for Galantamine 12 mg film-coated tablets, USP, containing 60 tablets. The label states the active ingredient is galantamine hydrobromide USP equivalent to 12 mg galantamine base per tablet. It is distributed by Rising Health, LLC, and labeled by Rising Pharma Holdings, Inc. The label includes storage instructions and a barcode.*
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Galantamine Fig2

Galantamine Fig2
A line graph showing cumulative percentage of patients plotted against ADAS-cog change from baseline, comparing placebo and three doses of galantamine (8 mg/day, 16 mg/day, and 24 mg/day). The graph illustrates cognitive change with marked lines at -10, -7, -4 points, and no change.*
FDA Label Image

Galantamine Fig3

Galantamine Fig3
A bar chart depicting the percentage of patients by CIBIC-plus rating categories (Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, Markedly Worse). Four groups are compared: Placebo, 8 mg/day, 16 mg/day, and 24 mg/day doses of Galantamine tablets. The chart shows patient outcome distribution across these dosing groups.*
FDA Label Image

Galantamine Fig4

Galantamine Fig4
A line graph showing mean change from baseline in ADAS-cog score over 26 weeks of treatment in three groups: placebo, 24 mg/day, and 32 mg/day. The y-axis represents mean change in score with improvement upward and decline downward, and the x-axis shows weeks of treatment at 0, 3, 13, and 26 weeks. Both 24 mg/day and 32 mg/day groups show improvement from baseline, whereas the placebo group shows decline over time.*
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Figure 5 (Galantamine Fig5)

Figure 5 (Galantamine Fig5)
A cumulative percentage of patients chart showing ADAS-cog change from baseline. The graph compares placebo, 24 mg/day, and 32 mg/day dosing groups of Galantamine tablets, with patients distributed across a range from -15 to +15 points change in ADAS-cog scores.*
FDA Label Image

Galantamine Fig6

Galantamine Fig6
A bar chart showing the percentage of patients by CIBIC-plus Rating categories for Placebo, 24 mg/day, and 32 mg/day doses. Categories range from Markedly Improved to Markedly Worse, including No Change. The chart compares the distribution of patient responses across treatment groups.*
FDA Label Image

Galantamine Fig7

Galantamine Fig7
A line graph showing the mean (±SE) change from baseline in ADAS-Cog score over 26 weeks of treatment. It compares three groups: placebo, 24 mg/day, and 32 mg/day of a treatment. The y-axis indicates improvement (negative change) and decline (positive change), while the x-axis represents weeks of treatment at 0, 3, 13, and 26 weeks.*
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Figure 8 (Galantamine Fig8)

Figure 8 (Galantamine Fig8)
A cumulative percentage curve chart showing ADAS-cog change from baseline among patients. The x-axis represents ADAS-cog change from -15 to +15, and the y-axis shows cumulative percentage of patients from 0% to 100%. Data for placebo and two dosage groups, 24 mg/day and 32 mg/day, are depicted with distinct lines and markers, with reference points noted at -10, -7, -4 points and No Change.*
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Galantamine Fig9

Galantamine Fig9
A bar graph depicting patient response distribution for Galantamine doses (24 mg/day and 32 mg/day) compared to placebo. The x-axis shows response categories from markedly improved to markedly worse, and the y-axis shows the percentage of patients. The graph compares placebo, 24 mg/day, and 32 mg/day results across these categories.*
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Structure (Galantamine Str)

Structure (Galantamine Str)
Chemical structure of Galantamine hydrobromide (HBr), showing its atomic arrangement including oxygen, nitrogen, and methyl groups in a multi-ring molecular structure.*

* 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.