MIMS Revision Date: 01 May 2026

1 Name of Medicine

Paracetamol.
Pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Panadol Sinus Relief Original Formula Tablets contain pseudoephedrine hydrochloride 30 mg and paracetamol 500 mg.
Excipient with known effect. Sodium benzoate as a preservative.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Panadol Sinus Relief Original Formula Tablets are white, capsule-shaped tablets with flat edges debossed with I - I on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Panadol Sinus Relief Original Formula Tablets are used for the temporary relief of sinus congestion and pain, nasal congestion and runny nose.

4.2 Dose and Method of Administration

Adults and children 12 years and over. 2 capsule shaped tablets (caplets) taken with water every 6 hours as necessary, maximum 8 caplets within 24 hours.
Use in adults. Paracetamol should not be taken for more than a few days at a time except on medical advice.
Use in children aged 12 to 17 years. Paracetamol should not be taken for more than 48 hours except on medical advice. Do not use in children below 12 years of age.
Do not exceed the stated dose or frequency of dosing.
Minimum dosage interval: 6 hours.
The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.
Do not use with other paracetamol containing or decongestant products including cough and cold preparations.
Seek medical advice if symptoms persist for more than 7 days.

4.3 Contraindications

This product is contraindicated for use in patients:
with known hypersensitivity or idiosyncratic reaction to paracetamol, pseudoephedrine or any of the other ingredients in the product;
with severe or uncontrolled hypertension or severe coronary artery disease;
who are receiving other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants);
who are receiving monoamine oxidase inhibitors (MAOIs) or for two weeks after stopping a MAOI drug;
with severe acute or chronic kidney disease/renal failure;
who are taking oxazolidinone class of antibiotics including furazolidone and linezolid (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Contains paracetamol. Do not use with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Concomitant use of other cold and flu medicines should be avoided.

4.4 Special Warnings and Precautions for Use

Identified precautions. This product should be used with caution in patients with: cardiovascular disease; arrhythmias; hypertension; prostatic enlargement; phaeochromocytoma; hyperthyroidism; diabetes mellitus; raised intraocular pressure including glaucoma; epilepsy; bronchitis; bronchiectasis; bronchial asthma.
Liver and kidney impairment. Caution should be exercised in patients with kidney impairment and in those with hepatic impairment due to the paracetamol content of this medicine. Underlying liver disease increases the risk of paracetamol-related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
In patients with glutathione depleted states such as sepsis, the use of paracetamol may increase the risk of metabolic acidosis.
Psychosis.
When planning surgery. Acute perioperative hypertension may occur if volatile halogenated anaesthetics are used simultaneously with indirect sympathomimetic agents. It is recommended that pseudoephedrine treatment be stopped 24 hours before anaesthesia.
Use with caution in patients taking beta-blockers or other antihypertensives or vasoconstrictive agents such as ergot alkaloids because of the pseudoephedrine content. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.
Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index, are chronic heavy users of alcohol or have sepsis.
There have been reports of acute systemic vasoconstrictive events with pseudoephedrine. Significant examples include:
Acute coronary syndrome (ACS): symptoms include sudden chest pain, tightness, heavy sweating and dyspnoea at rest.
Ischaemic colitis: symptoms included sudden abdominal pain and rectal bleeding.
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). 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). 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.
Pseudoephedrine should be discontinued immediately and medical advice sought if any signs/symptoms of vasoconstrictive events develop. Pseudoephedrine content of this product may result in a positive reaction during antidoping control tests.
Medical advice should be sought if the symptoms persist, or is accompanied by a high fever, skin rash or persistent headache.
If symptoms persist, medical advice must be sought. Keep out of sight and reach of children.
Patients should be advised not to drive or operate machinery if affected by dizziness. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.
High anion gap metabolic acidosis. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or patients with malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
Use in hepatic impairment. Caution should be exercised in patients with hepatic impairment due to the paracetamol content of this medicine.
Underlying liver disease increases the risk of paracetamol-related liver damage.
Patients who have been diagnosed with liver impairment must seek medical advice before taking this medication.
Use in renal impairment. Caution should be exercised in patients with kidney impairment due to the paracetamol and pseudoephedrine content of this medicine. Pseudoephedrine is primarily excreted renally.
Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication.
This product is contraindicated for use in patients with severe renal impairment.
Use in the elderly. Use with caution in patients over the age of 60 years. Patients in this age group are at greater risk of adverse reactions due to decreased renal function, and unwanted reactions when using oral sympathomimetic agents.
Paediatric use. Do not give to children under 12 years of age.
Effects on laboratory tests. No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Paracetamol. The following interactions with paracetamol have been noted.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol containing products with increased risk of bleeding; occasional doses have no significant effect.
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.
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see Section 4.4).
Pseudoephedrine. The following interactions with pseudoephedrine have been noted.
Antidepressant medication, e.g. tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs), may cause a serious increase in blood pressure or hypertensive crisis.
Concomitant administration of pseudoephedrine and MAOIs (or within two weeks of stopping of MAOI) may lead to hypertensive crisis (see Section 4.3 Contraindications).
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure (see Section 4.3 Contraindications).
Pseudoephedrine may antagonise the effect of certain classes of antihypertensives (e.g. β-blockers, methyldopa, reserpine, debrisoquine, guanethidine) (see Section 4.4 Special Warnings and Precautions for Use).
Methyldopa and β-blockers may cause an increase in blood pressure.
Urinary acidifiers enhance elimination of pseudoephedrine.
Urinary alkalinisers decrease elimination of pseudoephedrine.
Pseudoephedrine-containing products may antagonise the effect of certain classes of antihypertensives.
The oxazolidinone class of antibiotics are known to cause a dose-related inhibition of monoamine oxidase. Therefore, they should not be taken with pseudoephedrine as there is a potential to cause hypertensive crisis.
Pseudoephedrine may interact with halogenated anaesthetics and may cause acute perioperative hypertension (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant administration of pseudoephedrine with vasoconstrictive agents including ergot derivatives may cause an increased risk of ergotism (see Section 4.4 Special Warnings and Precautions for Use).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. (Category B2)
There are insufficient data regarding the use of the product in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Avoid the use of the product during pregnancy, unless the benefits to the pregnant woman outweigh the risks to the foetus. If used, the lowest effective dose and shortest duration of treatment should be considered.
Pseudoephedrine. Drugs which have 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.
Although pseudoephedrine has been in widespread use for many years, its safe use during pregnancy has not been established.
Paracetamol. Category A. Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
This product should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the foetus.
This product should not be used in pregnancy without medical advice.
Use in lactation. This product should not be used whilst breastfeeding without medical advice.
Paracetamol is excreted in small amounts (< 0.2%) in breast milk but the effect of this on breastfed infants is unknown. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infants.
Pseudoephedrine is secreted in breast milk in small amounts. It has been estimated that 0.5% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in the breast milk over 24 hours but the effect of this on the breast fed infant is unknown.
Therefore it is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant. If used, the lowest effective dose and shortest duration of treatment should be considered.

4.7 Effects on Ability to Drive and Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness.

4.8 Adverse Effects (Undesirable Effects)

Adverse events from extensive postmarketing experience at therapeutic/ labelled dose and considered attributable are tabulated in Table 1 by system organ class and frequency.
The following convention has been utilised for the classification of undesirable effects: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Adverse event frequencies have been estimated from spontaneous reports received through postmarketing data.

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

Poisons information centre. If an overdose is taken or suspected, immediately contact the Poisons Information Centre (in Australia, call 131 126) for advice, or the patient should go to the hospital straight away even if they feel well because of the risk of delayed, serious liver damage. See Section 4.8 Adverse Effects (Undesirable Effects).
Treatment-paracetamol. Paracetamol overdose may cause liver failure which can lead to liver transplant or death. Acute pancreatitis has been observed with hepatic dysfunction and liver toxicity.
Immediate medical management is required in the event of overdose, even if the symptoms of overdose are not present.
Administration of N-acetylcysteine or methionine may be required.
Treatment-pseudoephedrine. Pseudoephedrine overdose may result in symptoms due to central nervous system and cardiovascular stimulation, e.g. excitement, restlessness, hallucinations, hypertension and arrhythmias. In severe cases, psychosis, convulsions, coma and hypertensive crisis may occur. Serum potassium levels may be low due to the extracellular to intracellular shifts in potassium.
Treatment should consist of standard supportive measures.

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 pressor 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.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

Paracetamol. 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 sulphate 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 sulphate conjugate being predominant.
Pseudoephedrine. 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.

5.3 Preclinical Safety Data

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

6 Pharmaceutical Particulars

6.1 List of Excipients

Panadol Sinus Original Formula tablets contain the excipients: purified talc, maize starch, pregelatinised maize starch, stearic acid, povidone, sodium benzoate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

3 years.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Panadol Sinus Original Formula Tablets are available in blister packs of the following sizes: 24 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure. Paracetamol.

Pseudoephedrine hydrochloride.
CAS number. Paracetamol. CAS registry number: 103-90-2.
Pseudoephedrine hydrochloride. CAS registry number: 345-78-8.

7 Medicine Schedule (Poisons Standard)

Schedule 3 Pharmacist Only Medicine.

Date of First Approval

18 February 1992

Date of Revision

03 March 2026

Summary Table of Changes