Finished product reference

Acetaminophen / Chlorpheniramine / Dextromethorphan / Phenylephrine / Ascorbic Acid

Tablet · Oral · 500 mg/2 mg/15 mg/5 mg/38 mg

List code
53455
Pharmacologic class
Combination cold and flu preparation (analgesic-antipyretic, antihistamine, antitussive, decongestant, vitamin)

What it is and how it works

Paracetamol provides analgesia and antipyresis; chlorphenamine is a sedating H1-antihistamine reducing rhinorrhoea and sneezing; dextromethorphan is a centrally acting cough suppressant; phenylephrine is an alpha-1 adrenergic agonist that causes nasal decongestion; ascorbic acid is vitamin C.

Indications

Short-term symptomatic relief of common cold and influenza symptoms including fever, aches, nasal congestion, rhinorrhoea and dry cough.

Contraindications

Hypersensitivity to any component; severe hypertension or coronary disease; use with or within 14 days of MAO inhibitors; severe hepatic impairment.

Warnings and precautions

Do not combine with other paracetamol-containing products because of the risk of hepatotoxicity in overdose. Causes drowsiness; avoid alcohol and driving. Use with caution in hypertension, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy and in the elderly; dextromethorphan may contribute to serotonin syndrome with serotonergic drugs.

Pregnancy

Generally avoided in pregnancy, particularly in the first trimester, because of the decongestant component.

Storage and supply

Store below 25 °C in a dry place, 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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