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Medicines
United States
Paracetamol

FDA 2023

Paracetamol, Ibuprofen

Combogesic

325MG; 97.5MG tabletUnited StatesMarketedAuthorised 1 Mar 2023

Open in the registerAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

CombogesicCanada · 325 MG + 97.5 MG · Tablet · Aft Pharmaceuticals (Can) LimitedSame brand
Combogesic IVCanada · 10 MG / ML + 3 MG / ML · Solution · Aft Pharmaceuticals (Can) LimitedSame brand
Combogesic 500 mg/150 mg filmom obložene tableteCroatia · filmom obložena tableta · Swixx Biopharma Kft.Same brand
Combogesic®Serbia · 500mg+150mg · film tableta · Amicus SRB D.O.O.Same brand
Combogesic®Serbia · 32mg/mL+9.6mg/mL · oralna suspenzija · Amicus SRB D.O.O.Same brand
Advil Plus AcetaminophenCanada · 250 MG + 125 MG · Tablet · Haleon Canada UlcSame form

More with the same substance on this register

Acetaminophen and IbuprofenParacetamol + Ibuprofen · 250MG; 125MG · tabletUnited States
Advil Dual Action with AcetaminophenParacetamol + Ibuprofen · 250MG; 125MG · tabletUnited States

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Antidol Dual 500 MG/200 MG Comprimidos Recubiertos con Película

Spain · 500 mg + 200 mg · comprimido recubierto con película · Laboratorios Cinfa S.A.

Same form

🇪🇸Dalsydol Duo 500 MG/200 MG Comprimidos Recubiertos con PeliculaSpain · 500 mg + 200 mg · comprimido recubierto con película · Viatris Healthcare LimitedSame form

🇪🇸Dolostop Plus 500 MG/150 MG Comprimidos Recubiertos con PeliculaSpain · 500 mg + 150 mg · comprimido recubierto con película · Kern Pharma S.L.Same form

🇭🇷BlokMAX Duo 500 mg/200 mg filmom obložene tableteCroatia · filmom obložena tableta · Alkaloid - INT d.o.o.Same form

🇭🇷Brufen Akut Duo 500 mg/200 mg filmom obložene tableteCroatia · filmom obložena tableta · Viatris LimitedSame form

🇳🇱Nuralgan 500 mg/200 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Laboratoires S.M.B. S.A.Same form

🇳🇱Parabufin 500 mg/200 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Teva B.V.Same form

🇳🇱Paracetamol/Ibuprofen AFTPharm 500 mg/150 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · AFT Pharmaceuticals (EUR) LimitedSame form

🇷🇸Avebol®Serbia · 500mg+200mg · film tableta · Ave & Vetmedic DOO BeogradSame form

🇸🇬Maxigesic Tablet 500MG/150MGSingapore · 150 MG + 500 MG · tablet, film coated · United Italian Trading Corporation (Private) LimitedSame form

🇸🇬NUROMOL FILM COATED TABLET 200mg/500mgSingapore · 200mg + 500mg · tablet, film coated · Reckitt Benckiser (Singapore) Pte LTDSame form

🇧🇷DualgiBrazil · Eurofarma Laboratorios S.A.Same substance

🇧🇷ibuprofeno + paracetamolBrazil · Eurofarma Laboratorios S.A.Same substance

🇧🇷LuftafemBrazil · Reckitt Benckiser (Brasil) LtdaSame substance

🇸🇬Maxigesic IV Solution for Infusion 1000MG/300MG per 100ML VialSingapore · 300mg + 1000mg/100ml · infusion, solution · Apex Pharma Marketing Pte. LTD.Same substance

Packs

Pack	Code	Status
ACETAMINOPHEN 325MG; IBUPROFEN 97.5MG	NDA209471-001	Prescription

Documents

The official texts, at the regulator.

Register entryFDA

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

U.S. Food and Drug Administration (Drugs@FDA) and openFDA drug labels

Source: U.S. Food and Drug Administration, Drugs@FDA and openFDA drug labels (imported 10 June 2026). Not endorsed by the FDA.

Licence: Public domain (U.S. Government work); openFDA terms · Added 10 Jun 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substances: Paracetamol, Ibuprofen
Strength: 325MG; 97.5MG
Dosage form: tablet
Route: oral
Register: United States (FDA)
Status: Marketed
Authorised: 1 Mar 2023
Registration: NDA 209471
Marketing authorisation holder: Aft Pharms US
Procedure: NDA
Supply: Prescription

FDACombogesic IVParacetamol + Ibuprofen · 1GM/100ML (10MG/ML); 300MG BASE/100ML · solution🇺🇸United States