CODOXOL Tablet Ref.[108824] Active ingredients: Caffeine Codeine Doxylamine Paracetamol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext. 1, Roodepoort 1724, South Africa

Product name and form

CODOXOL tablets.

Pharmaceutical Form

Tablets.

Round, yellow flat tablet scored on one side.

Qualitative and quantitative composition

Each tablet contains:

Codeine phosphate 10 mg
Doxylamine succinate 5 mg
Paracetamol 450 mg
Caffeine 30 mg

Sugar free.

For full list of excipients, see section 6.1.

Active Ingredient Description
Caffeine

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

Codeine

Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain. The anti-tussive activity of codeine is probably due to its depressant effect on the medullary cough centre in the brain.

Doxylamine

Doxylamine, an ethanolamine, first-generation antihistamine crosses the blood-brain barrier and exerts an antiemetic action by selectively binding to H1 receptors in the brain. Doxylamine is an antihistamine commonly used as a sleep aid. This drug is also used to relieve symptoms of hay fever (allergic rhinitis), hives (rash or itching), and other allergic reactions. Doxylamine is also a potent anticholinergic.

Paracetamol

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.

List of Excipients

Colloidal silicone dioxide
Magnesium stearate
Povidone
Quinolene yellow H8573 (C.I. 47005)
Sodium starch glycolate
Starch maize
Talc

Pack sizes and marketing

Blister packs of 10 tablets per blister strip.

20, 40 and 100 tablets in a securitainer and 1000 tablets in a white HDPE bottle.

Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext. 1, Roodepoort 1724, South Africa

Marketing authorization dates and numbers

34/2.8/0489

Namibia: NS1 14/2.8/0636

15 November 2002

Drugs

Drug Countries
CODOXOL South Africa

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