IBUPROFEN AND FAMOTIDINE 26.6 mg/1

Ibuprofen and famotidine · TABLET · Ascent Pharmaceuticals, Inc.

1 Recall on Record

Plain English

This prescription tablet combines ibuprofen, a pain reliever and anti-inflammatory medication, with famotidine, a histamine-2 receptor antagonist that reduces stomach acid. It is used to relieve pain and inflammation while helping protect the stomach from irritation.

Key Facts

Brand Name: IBUPROFEN AND FAMOTIDINE
Generic Name: Ibuprofen and famotidine
NDC Code (Product): 43602-544
Manufacturer: Ascent Pharmaceuticals, Inc.
Strength: 26.6 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA216814
Drug Class: Histamine-2 Receptor Antagonist [EPC]; Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start: 10/06/2022

Recall History

1 Recall on Record

Class II12/29/2023

Ascend Laboratories, LLC

Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

arthralgia3 reports

pain3 reports

alopecia2 reports

drug ineffective2 reports

rash2 reports

wheezing2 reports

abdominal discomfort1 reports

abdominal distension1 reports

anxiety1 reports

avian influenza1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies (14), Use in Specific Populations (8.5)] . Ibuprofen and famotidine tablet, a combination of a nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of ibuprofen and famotidine tablets and other treatment options before deciding to use ibuprofen and famotidine tablets. Use ibuprofen at the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)] . The recommended daily dose of ibuprofen and famotidine 800 mg/26.6 mg is a single tablet administered orally three times per day. Ibuprofen and famotidine tablets should be swallowed whole, and should not be cut to supply a lower dose. Do not chew, divide, or crush tablets. Patients should be instructed that if a dose is missed, it should be taken as soon possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose. Do not substitute ibuprofen and famotidine tablet with the single-ingredient products of ibuprofen and famotidine. One ibuprofen and famotidine tablet administered orally three times per day. (2) Use ibuprofen at the lowest effective d…

Contraindications

4 CONTRAINDICATIONS Ibuprofen and famotidine tablet is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ibuprofen or famotidine or any components of the drug product [see Warnings and Precautions (5.8, 5.11)] . History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.8, 5.10)] . In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)] . Ibuprofen and famotidine tablet should not be administered to patients with a history of hypersensitivity to other H 2 -receptor antagonists. Cross sensitivity with other H 2 -receptor antagonists has been observed. Known hypersensitivity to ibuprofen or famotidine or any components of the drug product. (4) History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. (4) In the setting of CABG surgery. (4) Known hypersensitivity to other H 2 -receptor antagonists. (4)

Drug Interactions

7 DRUG INTERACTIONS See Table 3 for clinically significant drug interactions with ibuprofen. See full prescribing information for a list of clinically important drug interactions. (7) table 3.1 table 3.2 table 3.3

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.4)] Hypertension [see Warnings and Precautions (5.5)] Heart Failure and Edema [see Warnings and Precautions (5.6)] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.7)] Anaphylactic Reactions [see Warnings and Precautions (5. 8)] Seizures [see Warnings and Precautions (5.9)] Serious Skin Reactions [see Warnings and Precautions (5.11)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.12)] Fetal Toxicity [see Warnings and Precautions (5.13)] Hematologic Toxicity [see Warnings and Precautions (5.14)] Aseptic Meningitis [see Warnings and Precautions (5.18)] Ophthalmological Effects [see Warnings and Precautions (5.19)] Most common adverse reactions (≥1% and greater than ibuprofen alone) are nausea, diarrhea, constipation, upper abdominal pain, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact…

Frequently Asked Questions

What is IBUPROFEN AND FAMOTIDINE used for?

Is IBUPROFEN AND FAMOTIDINE a controlled substance?

IBUPROFEN AND FAMOTIDINE is not classified as a controlled substance by the DEA.

What is the generic name for IBUPROFEN AND FAMOTIDINE?

The generic name for IBUPROFEN AND FAMOTIDINE is Ibuprofen and famotidine. There are 9 other brand versions of Ibuprofen and famotidine.

What is the NDC code for IBUPROFEN AND FAMOTIDINE 26.6 mg/1?

The NDC (National Drug Code) for IBUPROFEN AND FAMOTIDINE 26.6 mg/1 is 43602-544, listed by Ascent Pharmaceuticals, Inc..

Product NDC

43602-544

Package NDC

43602-544-05

Other IBUPROFEN AND FAMOTIDINE Dosages

Other Ibuprofen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)