Ibuprofen And Famotidine Tablet
Product Images NDC 85509-1315

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This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Ibuprofen And Famotidine (NDC 85509-1315). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Phoenix Rx Llc, 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

Image (1315 3)

Image (1315 3)
This text describes a medication containing 800 mg of ibuprofen and 26.6 mg of famotidine in each tablet. The dosage instructions advise checking the package insert for full prescribing information. The medication should be stored at 25°C with excursions allowed to 15-30°C. It is recommended for the pharmacist to dispense a medication guide to each patient. The product is in the form of tablets with a quantity of 30 tablets per package. The manufacturer is Ascent Pharmaceuticals, Inc., and it is repackaged by Phoenix RX LLC. The lot number and expiration date are provided as well.*
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5.11 (5.11)

5.11 (5.11)
This text discusses the risks associated with the premature closure of the fetal ductus arteriosus and the development of oligohydramnios and neonatal renal impairment due to the use of NSAIDs including Ibuprofen and famotidine during pregnancy. It highlights the importance of avoiding NSAID use at specific gestational periods to prevent these complications.*
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5.14 (5.14)

5.14 (5.14)
This text provides insights into the potential risks associated with maternal use of Ibuprofen during pregnancy. It mentions concerns such as premature closure of the fetal ductus arteriosus, oligohydramnios, neonatal renal impairment, and other complications in neonates exposed to Ibuprofen through maternal use. The text highlights the need for caution and monitoring when considering the use of NSAIDs like Ibuprofen during pregnancy, especially in relation to preterm labor. It also suggests that there are methodological limitations in some studies that make it challenging to establish a precise estimate of the risk of adverse fetal and neonatal outcomes.*
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Ibu-struct.jpg (Ibu Struct)

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Mg 2 (Mg2)

Mg 2 (Mg2)
This text appears to be a list of potential medical conditions or outcomes that may be associated with certain health issues or medications. It includes risks such as heart attack, stroke, liver problems including liver failure, high blood pressure, heart failure, kidney problems including kidney failure, allergic reactions, asthma attacks, skin reactions, and low red blood cells (anemia). It highlights the importance of monitoring and managing these health concerns to prevent more severe complications.*
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Mg 3 (Mg3)

Mg 3 (Mg3)
This text highlights common symptoms that may indicate a medical emergency. Symptoms such as shortness of breath, slurred speech, chest pain, swelling of the face or throat, or weakness in one part of your body can be signs of a serious condition and should not be ignored. If you are experiencing any of these symptoms, seek immediate medical attention.*
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Mg 4 (Mg4)

Mg 4 (Mg4)
This text appears to be a list of potential symptoms that may indicate various health issues, including nausea, weakness, diarrhea, itching, yellowing of the skin or eyes (jaundice), stomach pain, flu-like symptoms, presence of blood in vomit or bowel movements, black and sticky stools (melena), unusual weight gain, skin rash or blisters with fever, and swelling of the limbs. These symptoms suggest a range of possible health conditions that may require medical attention.*
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Famotidine-struct.jpg (Famotidine Struct)

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Mg 1 (Mg 1if)

Mg 1 (Mg 1if)
This text warns about the increased risk of heart attack or stroke, potentially leading to death, when taking medicines containing NSAIDs like Ibuprofen and famotidine. It advises against using these medications before or after heart surgery or a recent heart attack unless instructed by a healthcare provider. Furthermore, it mentions the risk of bleeding, ulcers, and perforation of the esophagus, stomach, and intestines with the use of NSAIDs, especially in individuals with certain health conditions or habits like smoking, alcohol consumption, or older age. It highlights that the risk of ulcers or bleeding is higher with a history of stomach ulcers, advanced liver disease, or prolonged use of NSAIDs.*
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Table 1 (Table 1)

Table 1 (Table 1)
This description provides a shift table of serum creatinine levels from normal to abnormal in controlled studies. The table includes data from Study 301 and Study 303, comparing baseline and post-baseline levels for Ibuprofen and Touprofen, as well as for Famotidine tablets. It shows the percentage of subjects falling under normal and abnormal ranges. The normal range for serum creatinine is indicated as 0.5-1.4 mg/dL or 44-124 micromol/L, with levels above 1.4 mg/dL considered abnormal.*
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Table 2.2 (Table 2.2)

Table 2.2 (Table 2.2)
This text provides a list of different medical issues categorized by organ systems including musculoskeletal and connective tissue disorders (such as ataxia and back pain), nervous system disorders (headache), respiratory and thoracic disorders (cough, pharyngolaryngeal pain), and vascular disorders like hypertension.*
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Table 2.1 (Table 2)

Table 2.1 (Table 2)
This is a table showing the incidence of adverse reactions in controlled studies for two different medications: Ibuprofen and Famotidine tablets. It includes the percentage of patients experiencing various side effects such as anemia, nausea, dyspepsia, diarrhea, constipation, abdominal pain, vomiting, edema, respiratory and sinus infections, bronchitis, and urinary tract infections.*
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Table 3.1 (Table 3.1)

Table 3.1 (Table 3.1)
This text discusses drugs that interfere with hemostasis, focusing on the clinical impact and interventions related to the concomitant use of ibuprofen, anticoagulants, NSAIDs, and aspirin. It highlights potential synergistic effects on bleeding and emphasizes the importance of monitoring patients for signs of bleeding when using these medications together. The text also touches upon the pharmacodynamic interactions between ibuprofen and aspirin, suggesting considerations for patients taking low-dose aspirin for cardioprotection. Furthermore, it warns against the concomitant use of ibuprofen, famotidine tablets, and analgesic doses of aspirin due to the increased risk of bleeding.*
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Table 3.2 (Table 3.2)

Table 3.2 (Table 3.2)
This is a list of drug interactions and clinical impacts involving NSAIDs like Ibuprofen, ACE inhibitors, Angiotensin Receptor Blockers (ARBs), Beta-blockers, diuretics, Digoxin, Lithium, and Methotrexate. It highlights potential risks such as diminished antihypertensive effects, acute renal failure, deteriorating renal function, and increased toxicity levels when these drugs are used together. The interventions suggested include monitoring blood pressure, kidney function, drug levels, and signs of toxicity to ensure patient safety and efficacy of treatment.*
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Table 3.3 (Table 3.3)

Table 3.3 (Table 3.3)
This document provides crucial information on drug interactions involving Cyclosporine, NSAIDs, Salicylates, Pemetrexed, and Tizanidine. It highlights the potential impacts, interventions, and precautions for each drug combination, emphasizing the importance of monitoring renal function, myelosuppression, and potential toxicity. Specific warnings are given for concomitant use of drugs like ibuprofen and famotidine with other medications like cyclosporine, Pemetrexed, and Tizanidine. Additionally, it advises against administering certain drugs dependent on gastric pH simultaneously with famotidine to avoid reduced absorption and loss of effectiveness. Overall, the document serves as a guide for healthcare professionals to manage and prevent harmful drug interactions effectively.*
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Tab4 (Table 4)

Tab4 (Table 4)
Table 4 presents the overall incidence rates of patients who developed at least one upper gastrointestinal or gastric ulcer in Study 301. The table shows the percentage of patients who developed ulcers while taking Ibuprofen and Pantoprazole versus Famotidine tablets, along with the corresponding P-values for the primary and secondary endpoints. The study evaluates the prevalence of upper gastrointestinal and gastric ulcers in patients receiving different treatments. The data includes the number of patients with ulcers out of the total number in each treatment group, allowing for a comparison of ulcer incidence between the two groups.*
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Tab5 (Table 5)

Tab5 (Table 5)
The text provides data on the overall incidence rate of patients who developed at least one gastric or upper gastrointestinal ulcer in Study 303 for Ibuprofen and Ibuprofen Pvalue® famotidine tablet. The primary endpoints included gastric ulcer and gastric ulcer™, with percentages reported for each. Secondary endpoints were upper gastrointestinal ulcer and upper gastrointestinal ulcer™, with corresponding percentages. The Cochran-Mants-Haerszel test was used for analysis. The text also mentions the classification of early terminated patients and criteria for classifying patients who terminated early due to adverse events or other reasons as having an ulcer.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.