Amoxicillin
Product Images NDC 10544-434

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Amoxicillin (NDC 10544-434). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Blenheim Pharmacal, 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

Label 875mg 20ct (Label Amoxicillin Caps 875mg Bpi(10544 434 20) West Ward(0143 9951 01) Rev1)

Packaging label for Amoxicillin Tablets USP 875mg by Blenheim Pharmacal, Inc. The label states the product contains 20 tablets with prescription use only. It includes storage instructions, manufacturer details, lot number, manufacturing and expiration dates in placeholder format, and a barcode. The label is primarily white with blue borders and black text.*

FDA Label Image

Table 1 (Amoxicillin 875 Hikma 1)

A dosing recommendations table for Amoxicillin covering adult and pediatric patients over 3 months of age. It details doses for different infections including ear/nose/throat, skin, genitourinary tract, lower respiratory tract, and gonorrhea, categorized by infection severity. The table includes typical adult doses and usual pediatric doses with relevant notes on dosing considerations for children under 2 years and weight-based dosing guidelines.*

FDA Label Image

Chemical Structure (Amoxicillin 875 Hikma 2)

Chemical structure diagram of the active ingredient amoxicillin showing its molecular components, including a beta-lactam ring and side chains with functional groups. The diagram includes labels for atoms and hydration with three water molecules (3H2O).*

FDA Label Image

Table 3 (Amoxicillin 875 Hikma 3)

A data table titled 'Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults.' It presents dose forms (400 mg suspension, 400 mg chewable tablet) and corresponding pharmacokinetic values: AUC0-∞ and Cmax of amoxicillin with standard deviations in mcg·hr/mL and mcg/mL respectively. The table notes administration timing and sample size.*

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Bacteria (Amoxicillin 875 Hikma 4)

A table displaying bacterial classifications, listing examples of Gram-positive bacteria on the left, including Enterococcus faecalis, Staphylococcus spp., Streptococcus pneumoniae, and alpha and beta-hemolytic streptococci; and Gram-negative bacteria on the right, including Escherichia coli, Haemophilus influenzae, Neisseria gonorrhoeae, Proteus mirabilis, and Helicobacter pylori.*

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Table 4 (Amoxicillin 875 Hikma 5)

A data table titled 'Susceptibility Test Interpretive Criteria for Amoxicillin' showing minimum inhibitory concentration (mcg/mL) and disk diffusion zone diameter (mm) breakpoints for various bacterial species categorized as susceptible, intermediate, or resistant to amoxicillin.*

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Table 5 (Amoxicillin 875 Hikma 6)

A table titled 'Acceptable Quality Control Ranges for Amoxicillin' listing bacteria species with their ATCC numbers, MIC ranges in mcg/mL, and Disk Diffusion Zone ranges in mm. It includes Escherichia coli, Enterococcus faecalis, Haemophilus influenzae, Staphylococcus aureus, and Streptococcus pneumoniae along with respective quality control ranges and a note explaining ATCC as the American Type Culture Collection.*

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Table 6 (Amoxicillin 875 Hikma 7)

A data table titled 'H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen.' It compares eradication rates from Study 1 and Study 2 using two analysis methods: Evaluable Analysis and Intent-to-Treat Analysis, each showing the percentage eradication rates with 95% confidence intervals and number of patients. Footnotes explain the criteria for patient inclusion in the analyses.*

FDA Label Image

Table 7 (Amoxicillin 875 Hikma 8)

A data table titled 'H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen' presenting eradication rates from two studies. It compares results using evaluable analysis and intent-to-treat analysis, including 95% confidence intervals and patient counts. Footnotes explain analysis criteria related to duodenal ulcer and H. pylori infection confirmation.*

* 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.