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Paracetamol + Chlorpheniramine + Phenylephrine

Symptomatic cold preparation: analgesic-antipyretic, H1-antihistamine, and sympathomimetic decongestant

ATC code: R05X(Other cold preparations)

Updated · Methodology

Indications

C

Common cold

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.

Sources

  1. AEMPS: Ficha técnica de Paracetamol + Clorfenamina + Fenilefrina (2024)
  2. Cochrane (Hemila and Chalker): Vitamin C for preventing and treating the common cold (2013)

ICD-10: J00 · ICD-11: CA00

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

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.

Safety

Contraindications

  • Hypersensitivity to any component
  • Severe hepatic impairment
  • Angle-closure glaucoma
  • Severe hypertension, CHD, tachyarrhythmia (phenylephrine)
  • Pheochromocytoma
  • Hyperthyroidism
  • Urinary retention (BPH)
  • Concomitant MAOI or use within 14 days
  • Pregnancy (phenylephrine), breastfeeding
  • Children under 12 (FDA 2008, EMA 2009)

Serious adverse effects

  • Acute liver failure with paracetamol overdose
  • Phenylephrine-induced hypertensive crisis and stroke in predisposed patients
  • Arrhythmias
  • Falls in older adults from chlorpheniramine
  • Anaphylaxis

Common adverse effects

  • Drowsiness
  • Dry mouth
  • Headache
  • Palpitations
  • Insomnia
  • Nausea
  • Constipation

Pregnancy: can you take Paracetamol + Chlorpheniramine + Phenylephrine?

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.

Breastfeeding: can you take Paracetamol + Chlorpheniramine + Phenylephrine?

Not recommended. Chlorpheniramine may reduce milk supply and sedate the infant (Hale L3). Phenylephrine reduces milk via vasoconstriction. Paracetamol alone is compatible (Hale L1).

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Drug interactions

With alcohol – paracetamol hepatotoxicity risk. With MAOIs – phenylephrine hypertensive crisis. With sedatives (benzodiazepines, opioids) – enhanced sedation from chlorpheniramine. In older adults – urinary retention, confusion, falls.

Timing and administration

No driving in the first days – chlorpheniramine causes drowsiness. Do not exceed total paracetamol 3–4 g/day, especially when combined with other paracetamol-containing products.

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Frequently asked

What is Paracetamol + Chlorpheniramine + Phenylephrine used for?

Paracetamol + Chlorpheniramine + Phenylephrine is evaluated for the following indications with varying evidence strength: Common cold (evidence tier C). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Paracetamol + Chlorpheniramine + Phenylephrine?

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.

Is Paracetamol + Chlorpheniramine + Phenylephrine safe during pregnancy?

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.

Is Paracetamol + Chlorpheniramine + Phenylephrine compatible with breastfeeding?

Not recommended. Chlorpheniramine may reduce milk supply and sedate the infant (Hale L3). Phenylephrine reduces milk via vasoconstriction. Paracetamol alone is compatible (Hale L1).

Can you drink alcohol while taking Paracetamol + Chlorpheniramine + Phenylephrine?

With alcohol – paracetamol hepatotoxicity risk.

Who should not take Paracetamol + Chlorpheniramine + Phenylephrine?

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.

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