Ibuprofen And Famotidine Tablet
Product Images NDC 85509-1315

Product Visual Gallery

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)

Label for Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg, oral tablet form, containing 30 tablets per bottle. The label indicates Rx only status and notes the product is manufactured by Ascent Pharmaceuticals, Inc. and repackaged by PHOENIX RX LLC in Hatboro, PA. It includes storage instructions and a QR code for the package insert.*

FDA Label Image

5.11 (5.11)

A text panel discussing the risk of premature closure of fetal ductus arteriosus with ibuprofen and famotidine use at about 30 weeks gestation or later during pregnancy. It also addresses the association of NSAID use at about 20 weeks gestation or later with fetal renal dysfunction, oligohydramnios, and neonatal renal impairment.*

FDA Label Image

5.14 (5.14)

A text panel discussing risks associated with ibuprofen use during pregnancy, including premature closure of the fetal ductus arteriosus, oligohydramnios, and neonatal renal impairment. It summarizes postmarketing reports, methodological limitations, and risks of delayed preterm labor related to NSAID use like ibuprofen.*

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Ibu-struct.jpg (Ibu Struct)

Chemical structure of ibuprofen, an active ingredient in the drug ibuprofen and famotidine. The diagram shows the molecule's key features including a benzene ring with attached functional groups.*

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Mg 2 (Mg2)

A text panel listing serious warnings and potential adverse effects associated with a medication, including heart attack, stroke, liver problems and failure, worsening 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 cell count (anemia).*

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Mg 3 (Mg3)

This image shows a partial drug facts or warning text panel listing 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.*

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Mg 4 (Mg4)

A partial text panel listing potential side effects including nausea, diarrhea, itching, yellowing of skin or eyes, indigestion, flu-like symptoms, vomiting blood, blood in bowel movements, unusual weight gain, skin rash, and swelling of extremities. The text is presented in bullet point format.*

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Famotidine-struct.jpg (Famotidine Struct)

Chemical structure diagram depicting the molecular structure of the active ingredient famotidine as part of the combination drug Ibuprofen and famotidine.*

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Mg 1 (Mg 1if)

A text panel listing warnings related to increased risks of heart attack, stroke, and gastrointestinal bleeding associated with ibuprofen and famotidine use. It details risk factors, cautions use around heart surgery and recent heart attacks, and notes the increased risk of ulcers or bleeding with specific conditions and medications.*

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Table 1 (Table 1)

A data table titled "Shift Table of Serum Creatinine, Normal** to Abnormal*** in Controlled Studies" showing the percentage and number of patients with normal and abnormal serum creatinine levels after baseline. It compares two studies (Study 301 and Study 303) with Ibuprofen and famotidine tablet and Ibuprofen alone, listing values for normal baseline shifting to abnormal post-baseline.*

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Table 2.2 (Table 2.2)

A data table listing adverse reaction categories and specific symptoms reported for a drug, including musculoskeletal and connective tissue disorders, nervous system disorders, respiratory and thoracic disorders, and vascular disorders, with corresponding numerical values for incidence.*

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Table 2.1 (Table 2)

A data table titled 'Incidence of Adverse Reactions in Controlled Studies' comparing percentages of various adverse reactions reported for ibuprofen and famotidine tablets (N=1022) versus ibuprofen alone (N=511). Categories include blood and lymphatic system disorders, gastrointestinal disorders, general disorders, infections, and infestations, with specific conditions and their incidence percentages listed side-by-side for each treatment group.*

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Table 3.1 (Table 3.1)

A text panel titled 'Drugs That Interfere with Hemostasis' summarizes clinical impact and intervention information related to ibuprofen, famotidine, and aspirin. It discusses the increased bleeding risk with concomitant use of ibuprofen and anticoagulants, interference of ibuprofen with aspirin's antiplatelet activity, and recommendations for patient monitoring and use caution with these drug combinations.*

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Table 3.2 (Table 3.2)

This image shows a detailed table discussing clinical impacts and interventions for drug interactions related to ibuprofen and famotidine. It covers interactions with ACE inhibitors, ARBs, beta-blockers, diuretics, digoxin, lithium, and methotrexate, highlighting effects on renal function, blood pressure, serum levels, and toxicity monitoring recommendations.*

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Table 3.3 (Table 3.3)

Text panel detailing drug interaction precautions and clinical impacts for ibuprofen and famotidine. It covers interactions with cyclosporine, NSAIDs and salicylates, pemetrexed, drugs dependent on gastric pH for absorption, and tizanidine (CYP1A2 substrate), including clinical impact summaries and recommended interventions during concomitant use.*

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Tab4 (Table 4)

A data table titled 'Overall Incidence Rates of Patients Who Developed at Least One Upper Gastrointestinal or Gastric Ulcer - Study 301' comparing percentages and counts of patients with ulcers between ibuprofen and famotidine tablets and ibuprofen alone. It presents primary and secondary endpoints, with associated p-values from statistical testing.*

FDA Label Image

Tab5 (Table 5)

A data table showing the overall incidence rate of patients who developed at least one gastric or upper gastrointestinal ulcer in Study 303. It compares the percentage and number of patients with ulcers between those taking ibuprofen and famotidine tablets versus ibuprofen alone, including primary and secondary endpoints with associated P-values.*

* 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.