Is Chlorphenamine + Ibuprofen + Pseudoephedrine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Chlorphenamine + Ibuprofen + Pseudoephedrine, including PROF Cold & Flu Film coated tablet (200,30,2 mg,mg,mg, Film-coated tablet, SAR 12.45).

Is Chlorphenamine + Ibuprofen + Pseudoephedrine approved by the US FDA?

Drugs@FDA lists 2 application product lines for Chlorphenamine + Ibuprofen + Pseudoephedrine, including ADVIL ALLERGY SINUS (Over-the-counter); CHILDREN'S ADVIL ALLERGY SINUS (Over-the-counter).

Active substances

Chlorphenamine + Ibuprofen + Pseudoephedrine

SFDA 1
US FDA 2
Health Canada 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
PROF Cold & Flu Film coated tablet	200,30,2 mg,mg,mg	Film-coated tablet · Oral use	20 Blister	SAR 12.45	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Valid

Indications — CHI Daman Drug Formulary

ACUTE COUGH; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ADVIL ALLERGY SINUS	2MG;200MG;30MG	tablet · oral	HALEON US HOLDINGS	Over-the-counter	19 Dec 2002
CHILDREN'S ADVIL ALLERGY SINUS	1MG/5ML;100MG/5ML;15MG/5ML	suspension · oral	HALEON US HOLDINGS	Over-the-counter	24 Feb 2004

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADVIL COLD & SINUS CONVENIENCE PACK	02399733	2 MG; 30 MG; 200 MG	KIT; TABLET · ORAL	HALEON CANADA ULC
ADVIL COLD & SINUS PLUS	02248645	200 MG; 2 MG; 30 MG	TABLET · ORAL	HALEON CANADA ULC
ADVIL COLD AND SINUS NIGHTTIME	02267632	2 MG; 200 MG; 30 MG	TABLET · ORAL	HALEON CANADA ULC
ADVIL COLD, SINUS & FLU EXTRA STRENGTH	02471604	60 MG; 400 MG; 4 MG	TABLET · ORAL	HALEON CANADA ULC
COLD + SINUS DAYTIME COLD + SINUS NIGHTTIME	02388030	2 MG; 30 MG; 200 MG	KIT; TABLET · ORAL	VITA HEALTH PRODUCTS INC
COLD + SINUS PLUS	02359243	2.0 MG; 30.0 MG; 200.0 MG	TABLET · ORAL	VITA HEALTH PRODUCTS INC

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.