DUEXIS Coated tablet Ref.[50734] Active ingredients: Famotidine Ibuprofen

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

DUEXIS (ibuprofen and famotidine) is supplied as a tablet for oral administration which combines the nonsteroidal anti- inflammatory drug, ibuprofen, and the histamine H2-receptor antagonist, famotidine.

Ibuprofen is (±)2(p-isobutylphenyl)propionic acid. Its chemical formula is C13H18O2 and molecular weight is 206.28. Ibuprofen is a white powder that is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone.

Its structural formula is:

Famotidine is N'-(aminosulfonyl)3[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. Its chemical formula is C8H15N7O2S3 and molecular weight is 337.45. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.

Its structural formula is:

Each DUEXIS tablet contains ibuprofen, USP (800 mg) and famotidine, USP (26.6 mg). The inactive ingredients in DUEXIS include: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, purified water, povidone, titanium dioxide, polyethylene glycol, polysorbate 80, polyvinyl alcohol, hypromellose, talc, FD&C Blue #2/Indigo Carmine Aluminum Lake, and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake.

Dosage Forms and Strengths

DUEXIS (ibuprofen and famotidine) tablets: 800 mg/26.6 mg, are light blue, oval, biconvex, film-coated tablets debossed with “HZT” on one side.

How Supplied

DUEXIS (ibuprofen and famotidine) tablets, 800 mg/26.6 mg, are light blue, oval, biconvex, film-coated tablets debossed with “HZT” on one side and supplied as:

NDC Number Size
75987-010-03 Bottle of 90 tablets

Distributed by: Horizon Medicines LLC, Deerfield, IL 60015

Drugs

Drug Countries
DUEXIS United States

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