ACTIFED Syrup Ref.[50592] Active ingredients: Pseudoephedrine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland

Product name and form

ACTIFED 30mg/1.25mg per 5ml Syrup.

Pharmaceutical Form

Syrup.

A clear, golden yellow syrup.

Qualitative and quantitative composition

ACTIFED Syrup contains 1.25 mg Triprolidine hydrochloride and 30 mg Pseudoephedrine hydrochloride in each 5 ml.

Excipients:

Also includes the following substances in each 5 ml:

Sucrose 3.5 g
Methyl Hydroxybenzoate (E218) 5.0 mg
Sunset Yellow (E110) 0.005 mg
Sodium benzoate 5.0 mg

For a full list of excipients, see section 6.1.

Active Ingredient Description
Pseudoephedrine

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.

List of Excipients

Sucrose
Glycerol
Methyl hydroxybenzoate (E218)
Sodium benzoate (E211)
Quinoline yellow (E104)
Sunset yellow (E110)
Water

Pack sizes and marketing

100 ml amber glass bottles with metal roll on closures or HDPE screw caps. Each cap type containing PVDC-lined wads or polyethylene/expanded polyethylene laminated wad.

100 ml amber glass bottles with a 3 piece plastic, child resistant, tamper evident closure fitted with a PVDC faced wad or polyethylene/expanded polyethylene laminated wad.

Not all pack sizes may be marketed.

Marketing authorization holder

Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0330/049/001

Date of first authorisation: 01 April 1978
Date of last renewal: 01 April 2008

Drugs

Drug Countries
ACTIFED Cyprus, Estonia, Ireland, Lithuania, Malta, Singapore, Turkey

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