Galantamine Hydrobromide Solution
Product Images NDC 0054-0137

Product Visual Gallery

This gallery contains 26 technical images submitted to the FDA as part of the official labeling for Galantamine Hydrobromide (NDC 0054-0137). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa 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

Bottle.jpg (Bottle)

Label for Galantamine Oral Solution USP 4 mg/mL, an oral liquid prescription drug. The label shows the NDC as 0054-0137-49 and includes dosage information stating each mL contains 4 mg galantamine hydrobromide USP. It includes storage instructions to keep at 20° to 25°C and not freeze. The manufacturer is West-Ward Pharmaceuticals Corp., Eatontown, NJ. The label includes barcode, lot, and expiration date fields.*

FDA Label Image

Chem.jpg (Chem)

Chemical structure of Galantamine Hydrobromide, showing the molecular arrangement including a methoxy-substituted aromatic ring, a bicyclic amine system, and hydroxyl groups, with hydrobromide indicated.*

FDA Label Image

Figure-1.jpg (Figure 1)

An instructional line drawing showing how to hold a bottle with one hand at the neck and use the other hand to twist the child-resistant cap open. The illustration demonstrates proper technique for opening a medication bottle, relevant for oral solution packaging like Galantamine Hydrobromide 4 mg/mL by Hikma Pharmaceuticals USA Inc.*

FDA Label Image

Gal-figure-1-01.jpg (Gal Figure 1 01)

Line graph depicting the mean (±SE) change from baseline in ADAS-cog scores over 21 weeks of treatment. Four groups are compared: Placebo, 8 mg/day, 16 mg/day, and 24 mg/day doses. The y-axis represents cognitive change with improvement indicated upward and decline downward, while the x-axis shows weeks of treatment (0, 4, 13, 21). Higher dose groups show cognitive score improvement over time compared to placebo.*

FDA Label Image

Gal-figure-10-01.jpg (Gal Figure 10 01)

A line graph showing mean change from baseline in ADAS-cog score over weeks of treatment (0, 4, 13) comparing placebo and 24 mg/day dosage. The y-axis indicates improvement (negative change) and decline (positive change). The 24 mg/day group shows improvement over time, while the placebo group remains near baseline or declines.*

FDA Label Image

Gal-figure-11-01.jpg (Gal Figure 11 01)

A cumulative percentage graph showing the ADAS-cog change from baseline in patients treated with either placebo or 24 mg or 32 mg/day of the drug. The x-axis represents ADAS-cog change values ranging from -15 to 15, with annotations indicating points of -10, -7, -4, and 'No Change'. The y-axis shows the cumulative percentage of patients from 0% to 100%. The placebo group is represented with a dotted line and circles, while the 24 mg or 32 mg/day group is shown with a solid line and triangles, indicating differences in cumulative patient outcomes between the treatment and placebo groups.*

FDA Label Image

Gal-figure-12-01.jpg (Gal Figure 12 01)

This bar chart compares the percentage of patients by CIBIC-plus rating categories between placebo and Galantamine Hydrobromide oral solution dosed at 24 mg or 32 mg per day. Categories range from Markedly Improved to Markedly Worse, showing distributions of patient outcomes under each treatment group.*

FDA Label Image

Gal-figure-2-01.jpg (Gal Figure 2 01)

Cumulative percentage plot showing the ADAS-cog change from baseline for patients receiving different doses of Galantamine Hydrobromide (8 mg/day, 16 mg/day, 24 mg/day) versus placebo. The x-axis represents the ADAS-cog change from baseline, while the y-axis shows the cumulative percentage of patients. Vertical lines indicate changes of -10, -7, -4 points, and no change.*

FDA Label Image

Gal-figure-3-01.jpg (Gal Figure 3 01)

A vertical bar chart showing the distribution of CIBIC-plus ratings among patients categorized by treatment groups: Placebo, 8 mg/day, 16 mg/day, and 24 mg/day. The x-axis displays seven clinical rating categories from "Markedly Improved" to "Markedly Worse." The y-axis represents the percentage of patients, ranging from 0 to 50%. Each treatment group is represented with distinct bar colors illustrating differences in patient outcomes across the rating categories.*

FDA Label Image

Gal-figure-4-01.jpg (Gal Figure 4 01)

A line graph depicting mean change from baseline in ADAS-cog score over 26 weeks of treatment. The graph compares three groups: placebo (dashed line with circles), 24 mg/day (solid line with squares), and 32 mg/day (dashed line with downward triangles). The y-axis ranges from -3 to 3, with negative values indicating improvement and positive values indicating decline in cognitive scores. Both 24 mg/day and 32 mg/day groups show improvement over time, whereas the placebo group shows decline after initial weeks.*

FDA Label Image

Gal-figure-5-01.jpg (Gal Figure 5 01)

A cumulative percentage line graph depicting the ADAS-cog change from baseline for patients treated with Galantamine Hydrobromide at doses of 24 mg/day and 32 mg/day compared with placebo. The x-axis shows ADAS-cog score changes ranging from -15 to 15, while the y-axis shows cumulative percentage of patients up to 100%. Three curves represent placebo (dotted line with circles), 24 mg/day (squares), and 32 mg/day (triangles) doses, illustrating the distribution of cognitive score changes among patient groups.*

FDA Label Image

Gal-figure-6-01.jpg (Gal Figure 6 01)

Bar chart depicting the percentage of patients by CIBIC-plus Rating categories (Markedly Improved to Markedly Worse) comparing placebo, 24 mg/day, and 32 mg/day dosages of Galantamine Hydrobromide. The vertical axis shows percentage of patients, and the horizontal axis lists rating categories.*

FDA Label Image

Gal-figure-7-01.jpg (Gal Figure 7 01)

A line graph depicting 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 doses. The x-axis shows weeks of treatment (0, 3, 13, 26), while the y-axis shows change in score, with improvement above and decline below the baseline.*

FDA Label Image

Gal-figure-8-01.jpg (Gal Figure 8 01)

A cumulative percentage graph showing ADAS-cog changes from baseline in patients. The x-axis represents ADAS-cog score changes, ranging from -15 to +15, and the y-axis represents the cumulative percentage of patients from 0% to 100%. Three curves compare placebo, 24 mg/day, and 32 mg/day dosages, indicating patient response distributions across these groups.*

FDA Label Image

Gal-figure-9-01.jpg (Gal Figure 9 01)

Bar chart showing the percentage of patients by CIBIC-plus Rating categories, comparing three groups: Placebo, 24 mg/day, and 32 mg/day. The x-axis lists categories from Markedly Improved to Markedly Worse, and the y-axis shows the percentage of patients from 0 to 60 percent. The chart illustrates patient distribution across efficacy and worsening ratings for different dosages and placebo.*

FDA Label Image

Patient-gal-figure2.jpg (Patient Gal Figure2)

Black and white line illustration showing two hands holding a bottle and a dropper. One hand grips the bottle, while the other inserts the dropper into the bottle opening, demonstrating how to use the dropper to extract or dispense liquid medication.*

FDA Label Image

Patient-gal-figure3a-2.jpg (Patient Gal Figure3a 2)

Illustration showing hands drawing liquid from a vial into a syringe, demonstrating the technique of withdrawing oral solution medication. No specific product labeling or branding is visible in the image.*

FDA Label Image

Patient-gal-figure3b.jpg (Patient Gal Figure3b)

An instructional line drawing showing two hands preparing a dose of oral solution using a syringe. One hand holds and squeezes a bottle upside down, while the other hand holds the syringe to draw liquid from the bottle's opening.*

FDA Label Image

Patient-gal-figure4a-2.jpg (Patient Gal Figure4a 2)

An instructional line drawing showing two hands preparing an oral solution dose by drawing liquid with a syringe from a bottle. The illustration depicts the proper technique to extract the medication, likely Galantamine Hydrobromide solution 4 mg/mL, in an oral liquid form for accurate dosing.*

FDA Label Image

Patient-gal-figure4b.jpg (Patient Gal Figure4b)

An instructional line drawing showing two hands: one holding a bottle and the other holding a syringe positioned above the bottle's opening, demonstrating the process of drawing liquid from the bottle into the syringe.*

FDA Label Image

Patient-gal-figure5a-2.jpg (Patient Gal Figure5a 2)

Line drawing illustration showing a hand holding an oral syringe above a cup held by another hand, demonstrating the preparation or administration of an oral liquid medication, likely related to Galantamine Hydrobromide oral solution.*

FDA Label Image

Patient-gal-figure5b-2.jpg (Patient Gal Figure5b 2)

An instructional line drawing showing a hand holding an oral syringe and dispensing liquid into a cup, demonstrating the administration process for an oral solution medication.*

FDA Label Image

Patient-gal-figure6-2.jpg (Patient Gal Figure6 2)

An illustration showing two hands; one hand holds a clear cup filled with liquid, while the other hand stirs the liquid with a spoon. This instructional image likely demonstrates how to mix or prepare an oral solution.*

FDA Label Image

Patient-gal-figure7.jpg (Patient Gal Figure7)

Black and white instructional illustration showing two hands opening a medication bottle with a child-resistant cap. The fingers grip the cap and bottle to twist it open, demonstrating safe bottle opening technique for oral liquid medications.*

FDA Label Image

Patient-gal-figure8a-2.jpg (Patient Gal Figure8a 2)

An instructional line drawing showing a hand holding an oral syringe above a disposable cup. The syringe appears to be used for measuring or administering liquid medication. The image likely demonstrates the proper technique for using an oral dosing syringe with a liquid solution.*

FDA Label Image

Patient-gal-figure8b-2.jpg (Patient Gal Figure8b 2)

An illustration depicting a hand holding an oral dosing syringe above a cup, demonstrating the measurement and administration of an oral solution medication.*

* 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.