MIMS Revision Date: 01 February 2026

1 Name of Medicine

Paracetamol and pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Each tablet contains paracetamol 500 mg and pseudoephedrine hydrochloride 30 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APOHealth Sinus & Pain Relief are capsule shaped, pink, uncoated tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

For the effective temporary relief of sinus pain and congestion. Relief of symptoms of sinusitis: nasal congestion, sinus congestion, headache, and sinus pain.

4.2 Dose and Method of Administration

Tablets should be swallowed with a glass of water. Tablets can be taken with or without food.
Take every 6 hours as necessary.
Adults and children over 12 years. 2 tablets. Do not exceed 8 tablets in 24 hours.
Children 7 - 12 years. 1 tablet. Do not exceed 4 tablets in 24 hours.
Keep to the recommended dose. Not recommended for children under 7 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 (MAOIs) or who have taken MAOIs within the previous 14 days.
Discontinue use and see a doctor at the first sign of a skin rash or any other sign of hypersensitivity.
See Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Pseudoephedrine should be used with caution in patients with hypertension, hyperthyroidism or thyroid disease, 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.
Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued, and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
If signs and symptoms such as formation of small pustules occur, with or without pyrexia or erythema, then treatment with pseudoephedrine should be discontinued and a physician should be consulted.
Paracetamol should be used in caution in patients with impaired hepatic function, impaired renal function, chronic alcoholism.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.
Use in hepatic impairment. Use with caution in patients with hepatic impairment or severe hepatic dysfunction.
Use in renal impairment. Use with caution in patients with renal impairment or renal dysfunction. 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. No data available.
Paediatric use. Not recommended for children under 7 years of age.
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;
colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol;
high anion gap metabolic acidosis from pyroglutamic acid (5-oxoprolinemia) has been reported with concomitant use of therapeutic doses of paracetamol and flucloxacillin. Patients reported to be most at risk are elderly females with underlying disease such as sepsis, renal function abnormality, and malnutrition.
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;
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.

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.
Paracetamol has 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.
Use in lactation. 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. Therefore, it is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.
Paracetamol is excreted in small amounts (< 0.2%) in breast milk. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infant.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Hypersensitivity reactions occur occasionally. Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage and rarely, acute renal tubular necrosis.
Children and the elderly are more likely to experience adverse effects than other age groups.
The safety of pseudoephedrine, paracetamol from clinical trial data is based on data from a randomized, placebo-controlled multi-dose clinical trial in the management of symptoms attributed to the paranasal sinus associated with the common cold.
Table 1 includes adverse events that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more. A dash represents an incidence of less than 1%.

The following additional adverse events were reported by ≥ 1% of subjects in randomized, placebo-controlled trials with single ingredient pseudoephedrine: dry mouth, nausea, dizziness and insomnia.
Adverse drug reactions identified during postmarketing experience with paracetamol, pseudoephedrine HCl or the combination appear in Table 2. The frequency category was estimated from spontaneous reporting rates according to the following convention: very common 1/10; common 1/100 and < 1/10; uncommon 1/1,000 and < 1/100; rare 1/10,000 and < 1/1000; very rare < 1/10,000; not known (cannot be estimated from the available 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 medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

If an overdose is taken or suspected, immediately contact the Poisons Information Centre (Ph: 131 126) for advice or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.
Overdosage with paracetamol if left untreated can result in severe, sometimes fatal, liver damage, and rarely, acute renal tubular necrosis.

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 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.

5.3 Preclinical Safety Data

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

6 Pharmaceutical Particulars

6.1 List of Excipients

The inactive ingredients are: microcrystalline cellulose, maize starch, colloidal anhydrous silica, povidone, croscarmellose sodium, stearic acid, magnesium stearate, sodium starch glycollate, glyceryl monostearate - self emulsifying and erythrosine ci45430 (127).

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

Blister packed size of 24 tablets in cardboard boxes.

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.

Molecular formula. Paracetamol. C₈H₉NO₂.
Pseudoephedrine hydrochloride. C₁₀H₁₅NO.
CAS number. Paracetamol. 103-90-2.
Pseudoephedrine hydrochloride. 345-78-8.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (S3).

Date of First Approval

20 January 2021

Date of Revision

03 December 2025

Summary Table of Changes