COLDREX Tablet Ref.[115926] Active ingredients: Caffeine Paracetamol Phenylephrine Vitamin C

Source: Web Search  Revision Year: 2012  Publisher: Manufacturer: S.C. Europharm S.A., 2 Panselelor str., Brasov, county of Brasov, 500419, Romania Marketing authorization holder: GlaxoSmithKline Consumer Healthcare, United Kingdom, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Product name and form

Coldrex Tablets.

Pharmaceutical Form

Tablet.

Qualitative and quantitative composition

Each tablet contains Paracetamol Ph.Eur. 500.0mg, Caffeine Ph.Eur. 25.0mg, Phenylephrine hydrochloride Ph Eur 5 mg, Terpin Hydrate BPC 20 mg, Ascorbic Acid 30 mg.

Active Ingredient

Caffeine is structurally related to the methylxanthines theophylline and theobromine. Caffeine's main action is as a CNS stimulant.

Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain.

Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha adrenergic activity and is without stimulating effects on the central nervous system. The sympathomimetic effect of phenylephrine produces vasoconstriction which in turn relieves nasal congestion.

Ascorbic acid, coupled with dehydroascorbic acid to which it is reversibly oxidised, has a variety of functions in cellular oxidation processes. Ascorbic acid is required in several important hydroxylations, including the conversion of proline to hydroxyproline and appears to have an important role in metal ion metabolism, including the gastrointestinal absorption of iron and its transport between plasma and storage organs.

List of Excipients

Maize starch
Soluble starch
Talc
Stearic acid
Polyvinyl pyrollidone
Potassium sorbate
Sodium lauryl sulphate
Sunset yellow

Pack sizes and marketing

Tablets. 12 tablets in blister (PVC/aluminum foil). One blister is packed in one cardboard cartons with patient information leaflet.

Marketing authorization holder

Manufacturer: S.C. Europharm S.A., 2 Panselelor str., Brasov, county of Brasov, 500419, Romania

Marketing authorization holder: GlaxoSmithKline Consumer Healthcare, United Kingdom, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Marketing authorization dates and numbers

PL 00071/5005R

23/02/2011

Drugs

Drug Countries
COLDREX Estonia, Hong Kong, Croatia, Lithuania, Poland

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