Midazolam Injection, Solution
Product Images NDC 0404-9915

15 FDA label images from Henry Schein, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Midazolam (NDC 0404-9915). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Henry Schein, 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

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Formula1.jpg (Formula1)
Chemical structure diagram of Midazolam hydrochloride, depicting the molecular arrangement including ring structures, nitrogen atoms, chlorine substitution, and indicated HCl component.*
FDA Label Image

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A data table titled 'Frequency of Observer's Assessment of Alertness/Sedation Composite Scores in One Study of Children Undergoing Procedures with Intravenous Midazolam for Sedation.' It displays age ranges from 1 to 17 years, sample sizes, and distribution of OAA/S scores from 1 (deep sleep) to 5 (alert), summarizing sedation levels across different childhood age groups.*
FDA Label Image

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A dosing information table for intramuscular administration of midazolam in pediatric patients (non-neonatal). It details sedation and anxiolysis use, typical doses ranging from 0.1 to 0.15 mg/kg, possible increase up to 0.5 mg/kg for anxious patients, and notes on dose reduction when combined with opioids.*
FDA Label Image

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This text panel provides detailed guidelines on the usual pediatric dosing of Midazolam injection solution for non-neonatal children. It explains sedation depth variation, titration methods, and dosing by specific pediatric age groups from less than 6 months to 12-16 years. Important considerations for dose adjustments with concomitant CNS depressants are included.*
FDA Label Image

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This text panel provides dosing information for midazolam injection, solution at 5 mg/mL for continuous intravenous infusion. It details usual pediatric (non-neonatal) and neonatal dosing protocols, including loading doses, infusion rates, clinical considerations for sedation and anxiolysis, and precautions for specific patient groups such as those with hepatic impairment or respiratory issues. The panel emphasizes weighing pharmacokinetic parameters and clinical experience for safe administration.*
FDA Label Image

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A data table showing units of sale and concentration for a product with NDC 0409-2587-05, available as a box of 10 vials or units, each with a concentration of 10 mg/10 mL (1 mg/mL).*
FDA Label Image

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Table showing units of sale and concentrations for Midazolam injection solution by Henry Schein, Inc. It lists two NDC codes with corresponding concentrations: one box of 10 vials containing 25 mg/5 mL (5 mg/mL) and another box of 10 vials containing 50 mg/10 mL (5 mg/mL).*
FDA Label Image

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This text panel presents the usual adult dose information for Midazolam injection solution given intramuscularly, primarily for preoperative sedation, anxiolysis, and amnesia. It details dosing recommendations based on patient age, risk factors, and cautions related to respiratory depression and concomitant drug use, including onset and peak sedation times.*
FDA Label Image

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Text panel providing dosing guidelines for Midazolam injection administered intravenously. It notes individualized and titrated dosing for sedation, anxiolysis, and amnesia during procedures, cautions to administer slowly over at least 2 minutes with evaluation of sedative effect, and references warnings related to cardiac and respiratory risks. It also mentions recommendations for narcotic premedication with certain procedures.*
FDA Label Image

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A text panel providing dosing instructions for Midazolam 1 mg/mL injection solution. It details dosing titration for healthy adults under 60, patients over 60 or debilitated patients, and maintenance dosing. It includes guidance on dose increments, timing, and adjustments when CNS depressant premedications are used.*
FDA Label Image

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This image shows a text panel discussing the induction of anesthesia using Midazolam injection. It details variable individual responses, dosing adjustments based on patient age, clinical status, and premedication status, and includes dosing recommendations for unpremedicated and premedicated patients, as well as considerations for severe systemic disease and use with other anesthetic agents.*
FDA Label Image

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Text panels from a Midazolam injection label detail guidance on dosage and administration for continuous infusion and incremental injections. The text covers adult dosing strategies, infusion rate titration, and considerations for sedation maintenance with diluted midazolam 5 mg/mL formulation.*
FDA Label Image

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A drug facts panel excerpt titled 'PEDIATRIC PATIENTS' discussing midazolam dosing specifics. It explains that pediatric patients typically receive midazolam in mg/kg increments, often at higher dosages than adults, with consideration for patient age and weight. It notes increased risks of respiratory effects when combined with opioids or sedatives and references boxed warnings and dosage instructions for monitoring pediatric sedation.*
FDA Label Image

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A data table titled 'Observer's Assessment of Alertness/Sedation (OAA/S)' displaying assessment categories for responsiveness, speech, facial expression, eyes, and composite scores ranging from 1 (deep sleep) to 5 (alert). The table details descriptions for each score level, such as normal speech and clear eyes at score 5, to no response at score 1.*
FDA Label Image

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Label1.jpg (Label1)
Label for Midazolam injection, USP, 25 mg/5 mL (5 mg/mL) solution in a fliptop vial. Intended for intravenous or intramuscular use, sterile. Packaged by Henry Schein, Inc. Includes storage instructions at 20 to 25°C (68 to 77°F), lot and expiration date placeholders, and barcode with NDC 0404-9915-05. Marked RX only.*

* 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.