MIMS Revision Date: 01 January 2026

1 Name of Medicine

Paracetamol, pseudoephedrine hydrochloride and chlorphenamine maleate.

2 Qualitative and Quantitative Composition

Each tablet contains paracetamol 500 mg, pseudoephedrine hydrochloride 30 mg and chlorphenamine maleate 2 mg as the active ingredients.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Chemists' Own Sinus + Allergy and Pain Relief are blue film coated oval tablets with a break-bar on one side and plain on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Chemists' Own Sinus + Allergy and Pain Relief tablets provide effective temporary relief from hayfever, nasal congestion, sinus pain, runny nose, sneezing sinus congestion and watery eyes.

4.2 Dose and Method of Administration

Adults and children over 12 years. Take 2 tablets 3 to 4 times a day as necessary. Keep to the recommended dose. Do not give to children under 12 years of age.
Use in adults. Paracetamol should not be taken for more than a few days at a time except on medical advice.
Use in children. Paracetamol should not be taken for more than 48 hours except on medical advice.

4.3 Contraindications

Paracetamol is contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to paracetamol (or any of the other ingredients in the product).
Pseudoephedrine is contraindicated for use in patients:
with known hypersensitivity or idiosyncratic reaction to pseudoephedrine (or any of the other ingredients in the product);
with severe or uncontrolled hypertension;
with severe coronary artery disease;
with severe acute or chronic kidney disease/renal failure;
taking monoamine oxidase inhibitors (MAOls) or who have taken MAOls within the previous 14 days.
Chlorphenamine is contraindicated for use in patients with:
a history of hypersensitivity to the substance or substances of similar chemical structure (or any of the other ingredients in the product);
narrow angle glaucoma;
stenosing peptic ulcer;
symptomatic prostatic hypertrophy;
bladder neck obstruction;
pyloroduodenal obstruction.
Chlorphenamine is contraindicated for use in:
newborns or premature infants;
lactating women;
patients taking monoamine oxidase inhibitors (MAOls).
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Paracetamol should be used with caution in patients with:
impaired hepatic function;
impaired renal function.
Pseudoephedrine should be used with caution in patients with:
hypertension;
hyperthyroidism;
diabetes mellitus;
coronary heart disease;
ischaemic heart disease;
glaucoma;
prostatic hypertrophy;
severe hepatic dysfunction.
Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Cases of PRES and RCVS have been reported with the use of pseudoephedrine-containing products (see Section 4.8 Adverse Effects (Undesirable Effects)). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see Section 4.3 Contraindications).
Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances. Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment.
Chlorphenamine may cause drowsiness and may increase the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided.
Use with caution in patients with epilepsy.
Use in hepatic impairment. Use with caution in patients with hepatic impairment.
Use in renal impairment. Use with caution in patients with renal impairment. Pseudoephedrine is contraindicated for use in patients with severe acute or chronic kidney disease/renal failure (see Section 4.3 Contraindications).
Use in the elderly. The elderly may experience paradoxical excitation with Chlorphenamine. The elderly are more likely to have central nervous system (CNS) depressive side effects, including confusion. (See Section 4.3 Contraindications).
Paediatric use. Children may experience paradoxical excitation with Chlorphenamine. (See Section 4.3 Contraindications).
Effects on laboratory tests. No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions with paracetamol have been noted:
Anticoagulant drugs (warfarin): dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time.
Paracetamol absorption is increased by substances that increase gastric emptying, e.g. metoclopramide.
Paracetamol absorption is decreased by substances that decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties, and narcotic analgesics.
Paracetamol may increase chloramphenicol concentrations.
The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes such as alcohol and anticonvulsant agents.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Cholestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
The following interactions with pseudoephedrine have been noted:
Antidepressant medication, e.g. tricyclic antidepressants and monoamine oxidase inhibitors (MAOls), may cause a serious increase in blood pressure or hypertensive crisis.
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants may cause an increase in blood pressure and additive effects.
Methyldopa and β-blockers may cause an increase in blood pressure.
Urinary acidifiers enhance elimination of pseudoephedrine.
Urinary alkalinisers decrease elimination of pseudoephedrine.
The following interactions with chlorphenamine have been noted:
Central nervous system (CNS) depressants (alcohol, sedatives, opioid analgesics, hypnotics) may cause an increase in sedation effects.
Monoamine oxidase inhibitors (MAOls) and tricyclic antidepressants (TCAs) may prolong and intensify the anticholinergic and CNS depressive effects.
Chlorphenamine when taken concomitantly with phenytoin may cause a decrease in phenytoin elimination.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. (Category B2)
Pseudoephedrine has been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data shows no evidence of an increased occurrence of foetal damage.
Pseudoephedrine should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the foetus.
Use in lactation. Paracetamol, pseudoephedrine and Chlorphenamine are excreted in breast milk and therefore this product it is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

4.7 Effects on Ability to Drive and Use Machines

CNS depressive effects of chlorphenamine include sedation and impaired performance (impaired driving performance, poor work performance, incoordination, reduced motor skills, and impaired information processing). Performance may be impaired in the absence of sedation and may persist the morning after a night-time dose.

4.8 Adverse Effects (Undesirable Effects)

Pseudoephedrine. Adverse effects include: cardiovascular stimulation: elevated blood pressure, tachycardia or arrhythmias.
Central nervous system (CNS) stimulation: restlessness, insomnia, anxiety, tremors and (rarely) hallucinations.
Skin rashes and urinary retention.
Children and the elderly are more likely to experience adverse effects than other age groups.
Nervous system disorders. Posterior reversible encephalopathy syndrome (PRES) (see Section 4.4 Special Warnings and Precautions for Use): frequency not known.
Reversible cerebral vasoconstriction syndrome (RCVS) (see Section 4.4 Special Warnings and Precautions for Use): frequency not known.
Paracetamol. Side effects of paracetamol are rare and usually mild, although haematological reactions have been reported. Skin rashes and hypersensitivity reactions occur occasionally. Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage and, rarely, acute renal tubular necrosis.
Chlorphenamine. Central nervous system (CNS) effects. CNS depressive effects of chlorphenamine include sedation and impaired performance (impaired driving performance, poor work performance, incoordination, reduced motor skills, and impaired information processing). Performance may be impaired in the absence of sedation and may persist the morning after a night-time dose.
CNS stimulatory effects of chlorphenamine may include anxiety, hallucinations, appetite stimulation, muscle dyskinesias and activation of epileptogenic foci.
High doses of chlorphenamine may cause nervousness, tremor, insomnia, agitation, and irritability.
Anticholinergic effects. Side effects of chlorpheniramine maleate associated with cholinergic blockage include dryness of the eyes, mouth and nose, blurred vision, urinary hesitancy and retention, constipation and tachycardia.
Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia), or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Paracetamol is a p-aminophenol derivative that exhibits analgesic and antipyretic activity. It does not possess anti-inflammatory activity. Paracetamol is thought to produce analgesia through a central inhibition of prostaglandin synthesis.
Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective decongestant in the upper respiratory tract. It is a stereoisomer of ephedrine and has a similar action, but has been found to have less presser activity and fewer central nervous system (CNS) effects.
Sympathomimetic agents are used as nasal decongestants to provide symptomatic relief. They act by causing vasoconstriction resulting in redistribution of local blood flow to reduce oedema of the nasal mucosa, thus improving ventilation, drainage and nasal stuffiness.
Chlorphenamine competes with histamine at central and peripheral histamine₁-receptor sites, preventing the histamine receptor interaction and subsequent mediator release.
Chlorpheniramine is a highly lipophilic molecule that readily crosses the blood brain barrier.
Chlorphenamine is highly selective for histamine₁-receptors but has little effect on histamine₂ or histamine₃ receptors. Chlorphenamine also activates 5-hydroxytryptamine (serotonin) and α-adrenergic receptors and blocks cholinergic receptors.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing doses. The elimination half-life varies from about 1 to 3 hours.
Paracetamol is metabolised extensively in the liver and excreted in the urine mainly as inactive glucuronide and sulfate conjugates. Less than 5% is excreted unchanged. The metabolites of paracetamol include a minor hydroxylated intermediate which has hepatotoxic activity. This intermediate metabolite is detoxified by conjugation with glutathione, however, it can accumulate following paracetamol overdosage (more than 150 mg/kg or 10 g total paracetamol ingested) and if left untreated can cause irreversible liver damage.
Paracetamol is metabolised differently by premature infants, newborns, infants and young children compared to adults, the sulfate conjugate being predominant.
Pseudoephedrine is readily absorbed from the gastrointestinal tract. It is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. It has a half-life of about 5-8 hours; elimination is enhanced and half-life reduced accordingly in acid urine. Small amounts are distributed into breast milk.
Chlorphenamine maleate is absorbed relatively slowly from the gastrointestinal tract, with peak plasma concentrations occurring about 2.5 to 6 hours after oral administration.
Chlorphenamine appears to undergo considerable first-pass metabolism. Bioavailability is low, values of 25 to 50% having been reported. About 70% of chlorphenamine in the circulation is bound to plasma proteins. There is wide interindividual variation in the pharmacokinetics of chlorphenamine; half-life values ranging from 2 to 43 hours have been reported. Chlorphenamine is widely distributed in the body and enters the CNS.
Chlorphenamine maleate is metabolised extensively. Metabolites include desmethyl and didesmethylchlorphenamine. Unchanged drug and metabolites are excreted primarily in the urine; excretion is dependent on urinary pH and flow rate. Only trace amounts have been found in the faeces.
A duration of action of 4 to 6 hours has been reported; this is shorter than may be predicted from pharmacokinetic parameters.
More rapid and extensive absorption, faster clearance, and a shorter half-life have been reported in children compared to adults.

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each tablet contains maize starch, microcrystalline cellulose, colloidal anhydrous silica, povidone, croscarmellose sodium, stearic acid, magnesium stearate, carnauba wax, brilliant blue FCF, titanium dioxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from moisture.

6.5 Nature and Contents of Container

Chemists' Own Sinus + Allergy and Pain Relief tablets are available in PVC/PVDC/Al blister packs containing 24 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure. Paracetamol.

C₈H₉NO₂.
Molecular weight: 151.2.
Pseudoephedrine hydrochloride.
C₁₀H₁₆ClNO.
Molecular weight: 201.7.
Chlorphenamine maleate.
C₂₀H₂₃ClN₂O₄.
Molecular weight: 390.9.
CAS number. Paracetamol: 103-90-2.
Pseudoephedrine hydrochloride: 345-78-8.
Chlorphenamine maleate: 113-92-8.

7 Medicine Schedule (Poisons Standard)

Schedule 3 - Pharmacist Only Medicine.

Date of First Approval

02 April 2003

Date of Revision

03 December 2025

Summary Table of Changes