Aminophylline Injection, Solution
Product Images NDC 0404-9813

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Aminophylline (NDC 0404-9813). 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

Formula1.jpg (Formula1)

Chemical structure of aminophylline dihydrate. The diagram shows the molecular formula C16H24N10O4 · 2(H2O) with structural details of the aminophylline molecule including water of hydration.*

FDA Label Image

Image1.jpg (Image1)

A data table titled 'Mean and Range of Total Body Clearance and Half-Life of Theophylline Related to Age and Altered Physiological States.' It shows population characteristics by age groups alongside corresponding mean and range values for total body clearance (mL/kg/min) and half-life (hours) of theophylline in various physiological states, including premature neonates, term infants, children, adults, and elderly subjects.*

FDA Label Image

Image10.jpg (Image10)

A data table titled 'Initial Theophylline Infusion Rates Following an Appropriate Loading Dose' detailing dosage rates for theophylline infusion by patient population and age. It includes neonates, infants, children, adolescents, adults, elderly, and patients with certain medical conditions, providing infusion rates in mg/kg/hr along with footnotes on dosage adjustments and target concentrations.*

FDA Label Image

Image11.jpg (Image11)

A data table titled 'Final Dosage Adjustment Guided by Serum Theophylline Concentration' outlining dosage recommendations for aminophylline based on peak serum concentration ranges. It provides specific infusion rate adjustments and monitoring intervals for concentrations from below 9.9 mcg/mL to above 30 mcg/mL, including guidance for stopping infusion and overdose treatment.*

FDA Label Image

Image12.jpg (Image12)

A table presenting unit of sale and total strength/total volume concentration for two NDC codes. The first NDC (0409-5921-01) corresponds to 250 mg per 10 mL (25 mg/mL) with 25 units in a carton. The second NDC (0409-5922-01) corresponds to 500 mg per 20 mL (25 mg/mL) with 25 units in a carton.*

FDA Label Image

Image2.jpg (Image2)

A data table presenting clearance values and reported ranges for aminophylline in various concurrent illnesses or altered physiological states, including acute pulmonary edema, COPD, cystic fibrosis, liver disease, pregnancy, sepsis, and thyroid disease. The table includes specific clearance measurements and notes on population variability and reporting standards.*

FDA Label Image

Image3.jpg (Image3)

A data table titled 'Clinically Significant Drug Interactions With Theophylline' listing various drugs, their type of interaction with theophylline, and the resulting effects. It includes drugs such as Adenosine, Alcohol, Allopurinol, Aminoglutethimide, Carbamazepine, Cimetidine, Ciprofloxacin, Clarithromycin, Diazepam, Disulfiram, Enoxacin, and Ephedrine, detailing how they increase or decrease theophylline clearance or affect drug activity.*

FDA Label Image

Image4.jpg (Image4)

A data table listing drug interactions affecting the clearance or plasma concentrations of theophylline. It includes drugs such as Erythromycin, Estrogen, Flurazepam, Halothane, Interferon alpha-A, Isoproterenol, Ketamine, Lithium, Lorazepam, Methotrexate, Mexiletine, Midazolam, and Moricizine, with notes on their pharmacologic effects and corresponding percentage increases or decreases in theophylline clearance or levels.*

FDA Label Image

Image5.jpg (Image5)

A data table listing various drugs and their effects on the clearance and pharmacologic interaction with theophylline. The table shows drugs such as Pancuronium, Pentoxifylline, Phenobarbital, Phenytoin, Propafenone, Propranolol, Rifampin, Sulfinpyrazone, Tacrine, Thiabendazole, Ticlopidine, Troleandomycin, and Verapamil, detailing how each affects theophylline clearance or serum levels and associated increase or decrease percentages.*

FDA Label Image

Image6.jpg (Image6)

This image displays a portion of text from a drug information panel referring to precautions and drug interactions for aminophylline. It mentions the average effect on steady-state theophylline concentration and variability in individual patient responses.*

FDA Label Image

Image7.jpg (Image7)

A data table titled 'Drugs That Have Been Documented Not to Interact With Theophylline or Drugs That Produce No Clinically Significant Interaction With Theophylline.' The table lists various drugs, including albuterol, amoxicillin, atenolol, azithromycin, caffeine, diltiazem, prednisone, and many others, organized in two columns. A note below references additional information in precautions and drug interactions sections.*

FDA Label Image

Image8.jpg (Image8)

A data table titled 'Manifestations of Theophylline Toxicity' showing the percentage of patients with various signs and symptoms reported in studies of acute overdose (large single ingestion) and chronic overdosage (multiple excessive doses). The table categorizes symptoms into gastrointestinal, metabolic/other, and cardiovascular groups, and reports data from four studies with different patient counts.*

FDA Label Image

Image9.jpg (Image9)

A data table summarizing adverse event frequency in patients with high serum theophylline concentrations from two studies. The table lists categories of cardiac and neurologic symptoms including ventricular arrhythmias, hypotension/shock, nervousness, tremors, disorientation, seizures, and death, along with corresponding numeric frequencies. Footnotes explain study details and data reporting methods.*

FDA Label Image

Label1.jpg (Label1)

Aminophylline injection, USP single dose solution at 25 mg/mL strength in a 10 mL vial. The label shows the product name, concentration, and dose volume (250 mg/10 mL). It includes storage instructions to keep at controlled room temperature 68F to 77F, caution to protect from light, and aseptic usage warnings. The label also displays the NDC code 0404-9813-10, manufacturer Henry Schein, Inc. with address, and placeholders for lot number and expiration date. The label indicates the product is for intravenous use and prescription 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.