Ibuprofen And Famotidine Tablet
Product Images NDC 80425-0384

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Ibuprofen And Famotidine (NDC 80425-0384). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Advanced Rx Pharmacy Of Tennessee, 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.

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5.11 (5.11)

A text panel discussing risks associated with the use of NSAIDs, including ibuprofen and famotidine tablets, during pregnancy at or beyond 20 to 30 weeks gestation. It addresses potential premature closure of the fetal ductus arteriosus and oligohydramnios or neonatal renal impairment linked to NSAID use in late pregnancy.*

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5.14 (5.14)

Text panel discussing safety considerations of ibuprofen use during pregnancy, specifically its potential effects on fetal ductus arteriosus closure, oligohydramnios, neonatal renal impairment, and risks related to delaying preterm labor. It summarizes postmarketing reports, study limitations, and potential neonatal complications associated with maternal NSAID use.*

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Ibu-struct.jpg (Ibu Struct)

Chemical structure of ibuprofen, showing a benzene ring with an isobutyl group and carboxylic acid functional group.*

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Label 1 (Ibuprofen Famotidine 800mg 26.6mg 80425 0384 01)

Label for IBUPROFEN AND FAMOTIDINE 800 mg/26.6 mg oral tablets from Advanced Rx Pharmacy of Tennessee, LLC. The label shows storage instructions, compares the product to DUEXIS with NDC 80425-0384-01, lot and expiration date fields, and a barcode. The package contains 30 tablets and is for prescription use.*

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Label2 (Ibuprofen Famotidine 800mg 26.6mg 80425 0384 02)

Packaging label for IBUPROFEN AND FAMOTIDINE 800-26.6MG TABLET by Advanced Rx Pharmacy of Tennessee, LLC. The label includes directions to store at 20°-25°C, batch/lot number, expiration date 3/31/2025, and prescription-only designation. The label references comparison to Duexis and provides the NDC code 80425-0384-02.*

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Label 3 (Ibuprofen Famotidine 800mg 26.6mg 80425 0384 03)

IBUPROFEN/FAMOTIDINE 800-26.6mg oral tablet label from Advanced Rx Pharmacy of Tennessee, LLC. The label includes storage instructions, lot number, expiration date of 3/31/2025, NDC numbers, and a barcode. It is marked as prescription only and compares to DUEXIS.*

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Mg 2 (Mg2)

A portion of a drug facts or warning panel listing serious potential adverse effects. These include heart attack, stroke, liver problems including liver failure, new or worse high blood pressure, heart failure, kidney problems including kidney failure, life-threatening allergic reactions, asthma attacks in people with asthma, life-threatening skin reactions, and low red blood cells (anemia).*

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Mg 3 (Mg3)

A drug facts or warning text panel listing possible adverse symptoms including shortness of breath, chest pain, weakness in one part or side of the body, slurred speech, and swelling of the face or throat. The text is presented as bullet points.*

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Mg 4 (Mg4)

Partial text panel listing adverse reactions and symptoms including nausea, vomiting blood, diarrhea, itching, unusual weight gain, and swelling of arms, legs, hands, and feet. This is part of the safety information for Ibuprofen and Famotidine tablets.*

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Famotidine-struct.jpg (Famotidine Struct)

Chemical structure diagram showing the molecular formula of the active ingredient famotidine as used in the Ibuprofen and Famotidine combination drug product.*

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Mg 1 (Mg 1if)

A text panel discussing the risks associated with ibuprofen and famotidine tablets, including increased risk of heart attack, stroke, bleeding, ulcers, and esophageal tears. It outlines factors that increase these risks such as dosage, length of use, medical history, and lifestyle factors.*

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Table 1 (Table 1)

A table titled 'Shift Table of Serum Creatinine, Normal to Abnormal in Controlled Studies' presenting data from two studies (301 and 303). It compares the percentage and number of subjects with serum creatinine levels shifting from normal to abnormal post-baseline for ibuprofen and famotidine tablet versus ibuprofen alone. Footnotes define serum creatinine normal and abnormal ranges.*

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Table 2.2 (Table 2.2)

A data table listing adverse events by system organ class for Ibuprofen and Famotidine tablets. It includes categories such as musculoskeletal disorders, nervous system disorders, respiratory disorders, and vascular disorders, with counts for specific symptoms like arthralgia, back pain, headache, cough, pharyngolaryngeal pain, and hypertension.*

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Table 2.1 (Table 2)

Table titled 'Incidence of Adverse Reactions in Controlled Studies' comparing percentages of various adverse reactions between Ibuprofen and famotidine tablets (N=1022) and Ibuprofen alone (N=511). Categories include blood and lymphatic system disorders, gastrointestinal disorders, general disorders, infections, and infestations with corresponding percentage incidences for each adverse reaction.*

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Table 3.1 (Table 3.1)

A drug facts text panel titled 'Drugs That Interfere with Hemostasis' describing clinical impact and intervention for ibuprofen with anticoagulants and aspirin. It details risks of bleeding when ibuprofen is combined with anticoagulants, serotonin reuptake inhibitors, aspirin, and NSAIDs, including recommendations for monitoring and contraindications for use with low-dose aspirin for cardiovascular protection.*

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Table 3.2 (Table 3.2)

This text panel details clinical impact and intervention guidance for concurrent use of ibuprofen and famotidine tablets with various drug classes including ACE inhibitors, ARBs, beta-blockers, diuretics, digoxin, lithium, and methotrexate. It summarizes potential effects such as altered drug efficacy, toxicity risks, and recommended monitoring during concomitant administration.*

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Table 3.3 (Table 3.3)

A drug interaction text panel detailing clinical impacts and recommended interventions for concomitant use of ibuprofen and famotidine with cyclosporine, NSAIDs and salicylates, pemetrexed, drugs dependent on gastric pH for absorption, and tizanidine (CYP1A2 substrate). It highlights risks such as increased nephrotoxicity, drug absorption issues, and increased blood concentrations, with monitoring guidance.*

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Tab4 (Table 4)

A data table presenting overall incidence rates of patients who developed at least one upper gastrointestinal or gastric ulcer in a clinical study. It compares percentages and counts for ibuprofen and famotidine tablets versus ibuprofen alone, highlighting primary and secondary endpoints along with associated p-values.*

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Tab5 (Table 5)

A clinical study data table titled 'Overall Incidence Rate of Patients Who Developed at Least One Gastric or Upper Gastrointestinal Ulcer - Study 303'. It compares the incidence rates of gastric and upper gastrointestinal ulcers between groups taking ibuprofen and famotidine tablets versus ibuprofen alone, showing percentages, sample sizes, and statistical p-values for primary and secondary endpoints.*

* 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.