Symptomatic cold preparation: analgesic-antipyretic, H1-antihistamine, and sympathomimetic decongestant
ATC code: R05X (Other cold preparations)
Paracetamol blocks central COX-2, lowering prostaglandin synthesis – antipyretic and analgesic effect. Chlorpheniramine is a first-generation H1-antihistamine with central sedative effect, dries mucosal secretions. Phenylephrine is a selective alpha-1 adrenoceptor agonist, constricts nasal mucosal vessels and reduces congestion. Oral phenylephrine bioavailability is 38% – its clinical decongestant efficacy is limited.
Third line
Symptomatic relief of cold symptoms in adults: fever, headache, muscle pain, runny nose, nasal congestion. Per SEMERGEN 2023 and Cochrane 2023, fixed cold combinations give modest short-term effect on individual symptoms; paracetamol monotherapy is more effective for pain and fever. Dose: typically 500-650 mg paracetamol + 4 mg chlorpheniramine + 10 mg phenylephrine every 4-6 hours, max 4 times daily. Course ≤3-5 days.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
The product is marketed as a remedy that shortens colds. Per Cochrane 2018 (Smith), Cochrane 2023, and AAFP 2022, cold combinations do not shorten viral URTI or prevent complications. Oral phenylephrine was judged ineffective as a nasal decongestant by the Advisory Committee in 2023 – regulatory reassessment is expected. Co-use with alcohol raises paracetamol hepatotoxicity risk; in older adults, chlorpheniramine raises falls and confusion risk (Beers Criteria). If prescribed for 7-10 days or for complication prevention, consider getting a second opinion.
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Not recommended. Paracetamol may be used in pregnancy short-term; phenylephrine and chlorpheniramine should not (vascular effects and sedation). For colds in pregnancy, prefer saline irrigation, humidification, and paracetamol monotherapy.
Not recommended. Chlorpheniramine may reduce milk supply and sedate the infant (Hale L3). Phenylephrine reduces milk via vasoconstriction. Paracetamol alone is compatible (Hale L1).
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Paracetamol + Chlorpheniramine + Phenylephrine is evaluated for the following indications with varying evidence strength: Common cold (evidence tier C), Acute viral upper respiratory infection (evidence tier D). See the full indication matrix with dosing and citations above on this page.
Common side effects of Paracetamol + Chlorpheniramine + Phenylephrine (≥ 1 in 100): Drowsiness, Dry mouth, Headache, Palpitations, Insomnia, Nausea. See the Safety section for uncommon and serious reactions.
FDA category C. Not recommended. Paracetamol may be used in pregnancy short-term; phenylephrine and chlorpheniramine should not (vascular effects and sedation). For colds in pregnancy, prefer saline irrigation, humidification, and paracetamol monotherapy.
Not recommended. Chlorpheniramine may reduce milk supply and sedate the infant (Hale L3). Phenylephrine reduces milk via vasoconstriction. Paracetamol alone is compatible (Hale L1).
Paracetamol + Chlorpheniramine + Phenylephrine is contraindicated in: Hypersensitivity to any component; Severe hepatic impairment; Angle-closure glaucoma; Severe hypertension, CHD, tachyarrhythmia (phenylephrine); Pheochromocytoma. Full list in the Safety section.