Finished product reference

Codeine Phosphate / Guaifenesin / Phenylephrine

Syrup · Oral · 10 mg/100 mg/5 mg/5mL · 60 mL

List code
51940
Pharmacologic class
Combination cough and cold preparation (opioid antitussive + expectorant + sympathomimetic decongestant)

What it is and how it works

Codeine is an opioid that suppresses the cough reflex centrally; guaifenesin is an expectorant thought to increase the volume and reduce the viscosity of bronchial secretions; phenylephrine is an alpha-adrenergic agonist that causes vasoconstriction of nasal mucosa, relieving congestion.

Indications

Short-term symptomatic relief of cough associated with nasal congestion in colds and upper respiratory tract infections.

Contraindications

Children under 12 years, known CYP2D6 ultra-rapid metabolisers, breastfeeding, respiratory depression or acute asthma, and concurrent or recent (within 14 days) MAOI therapy; severe hypertension or severe coronary artery disease.

Warnings and precautions

Codeine can cause respiratory depression, sedation and dependence, and its conversion to morphine varies with CYP2D6 genotype; avoid alcohol and other CNS depressants. Phenylephrine should be used with caution in hypertension, cardiovascular disease, hyperthyroidism, diabetes, prostatic hypertrophy and glaucoma. Not recommended for productive cough where suppression is undesirable.

Pregnancy

Generally avoided in pregnancy; opioid use near term can cause neonatal respiratory depression and withdrawal.

Storage and supply

Store below 25 °C, protected from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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