Lotronex
Product Images NDC 65483-895

6 FDA label images from Prometheus Laboratories Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Lotronex (NDC 65483-895). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Prometheus Laboratories 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

Chemical Structure (Lot00 0006 01)

Chemical Structure (Lot00 0006 01)
Chemical structure diagram of the active ingredient in LOTRONEX, showing the molecular arrangement including rings and functional groups such as nitrogen atoms, a ketone group, and methyl substitutions.*
FDA Label Image

Figure 1 (Lot00 0006 02)

Figure 1 (Lot00 0006 02)
A bar chart comparing the percent of patients between Placebo and LOTRONEX 1 mg B.I.D. across two grouped study sets (Studies 1 & 2 and Studies 3 & 4). The LOTRONEX bars are higher than Placebo in both groups, indicating a difference in outcomes between the treatments.*
FDA Label Image

Principal Display Panel (Lotronex 0.5 mg Bottle Label)

Principal Display Panel (Lotronex 0.5 mg Bottle Label)
LOTRONEX (alosetron hydrochloride) Tablets label showing 0.5 mg strength. The label states 30 tablets per package and advises storing at 20-25°C (68-77°F). It includes instructions that dispensing requires a medication guide. Labeler is Prometheus Laboratories Inc., San Diego, CA, with the product made in Canada. The label features barcode and lot/expiration fields.*
FDA Label Image

Principal Display Panel (Lotronex 0.5 mg Carton)

Principal Display Panel (Lotronex 0.5 mg Carton)
Packaging label for LOTRONEX 0.5 mg tablets by Prometheus Laboratories Inc. The label indicates each film-coated tablet contains alosetron hydrochloride equivalent to 0.5 mg alosetron. The package contains 30 tablets and includes instructions to see prescribing information and store at controlled room temperature. The label also features the Rx only designation and a pharmacist affix label box.*
FDA Label Image

Principal Display Panel (Lotronex 1 mg Bottle Label)

Principal Display Panel (Lotronex 1 mg Bottle Label)
LOTRENEX (alosetron hydrochloride) Tablets 1 mg label showing a package containing 30 film-coated tablets. The label includes dosage strength, prescription-only status, storage instructions (20-25°C), and manufacturer details: Prometheus Laboratories Inc., San Diego, CA. The label states that federal law requires dispensing with a Medication Guide and includes a green tablet imprint with 'GX CT1.' The product is made in Canada.*
FDA Label Image

Principal Display Panel (Lotronex 1 mg Carton)

Principal Display Panel (Lotronex 1 mg Carton)
Packaging label for LOTRONEX tablets containing alosetron hydrochloride. Each film-coated tablet has 1 mg alosetron. The package contains 30 tablets and is labeled for prescription use only. The product is manufactured by Prometheus Laboratories Inc., San Diego, CA, and made in Canada. Storage instructions and pharmacist affix label areas are also included on the label.*

* 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.