Product Name & Strength: Cofex Syrup. Each 5 ml contains: Chlorpheniramine Maleate 2 mg, Ammonium Chloride 50 mg, Ipecacuanha Tincture 0.1 mL, Anise Water conc. 0.1 mL, Sodium Citrate 50 mg, Citric Acid 10 mg, and Menthol 1.0 mg.
Indications (Approved Uses): Useful in the symptomatic relief and control of coughs. It provides antihistamine, expectorant, and demulcent actions, helping to promote the expulsion of secretions from the respiratory tract, thereby reducing bronchial and nasal congestion.
Contraindications (Safety Warnings): It is contraindicated in individuals with known hypersensitivity to any of the components of the preparation. It is contraindicated in neonates and premature infants owing to their increased susceptibility to the antimuscarinic effect of chlorpheniramine. It is also contraindicated in patients with hepatic or renal impairment and in acute attacks of asthma.
Side Effects (Adverse Reactions): Side effects are rare and usually mild, which may be reduced by taking the drug with meals. Large doses have an irritant effect on the gastrointestinal tract and may cause nausea, vomiting, and diarrhoea. Large doses of ammonium chloride may cause profound acidosis and hypokalemia. Excessive doses of ipecacuanha may cause heart adverse effects, including conduction abnormalities or myocardial infarction.
Instructions for Use / Dosage: For oral administration. (A) Adults and children 12 years and above: 10 ml three times daily. (B) Children 6-12 years: 5-10 ml three times daily. (C) Children 2-5 years: 5 ml three times daily. (D) Children 3 months - 1 year: 2.5 ml three times daily.
Regulatory Information: NAFDAC Registration Number: A4-1195. Manufactured by SKG - Pharma Ltd, Nigeria.