Chemists' Own Sinus and Nasal Decongestant tablets

MIMS Revision Date: 01 February 2026

1 Name of Medicine

Pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Chemists' Own Sinus and Nasal Decongestant tablets contain 60 mg of pseudoephedrine hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Chemists' Own Sinus and Nasal Decongestant tablets are a small white tablet with break bar and S/SH on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Fast effective relief from nasal congestion without drowsiness. Dries up secretions in the nose and sinuses making breathing easier. Relieves sinus pressure.

4.2 Dose and Method of Administration

Adults and children over 12 years. 1 tablet 3 to 4 times a day when necessary.
Maximum of 4 tablets in 24 hours. Not recommended for children under 12 years.

4.3 Contraindications

This medication should not be given to patients with:
Known hypersensitivity or idiosyncratic reaction to pseudoephedrine.
Known hypersensitivity or idiosyncratic reaction to any of the excipients in this preparation.
Severe or uncontrolled hypertension.
Severe coronary heart disease.
Severe acute or chronic kidney disease/renal failure.
Those taking MAOI's (and for 14 days after cessation of MAOI therapy - as it may precipitate a hypertensive crisis).
See 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, coronary heart disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, glaucoma, elevated intraocular pressure, and prostatic enlargement or bladder dysfunction.
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.
Pseudoephedrine may cause sleeplessness if taken up to several hours before going to bed in sensitive people.
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.
Use in hepatic impairment. Pseudoephedrine should be used with caution in patients with severe hepatic dysfunction.
Use in 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. No data available.
Paediatric use. Not recommended for use in children under 12 years of age.
Effects on laboratory tests. No data available.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Pseudoephedrine may partially reverse the hypotensive action of drugs that interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa and beta-adrenergic blocking agents.
Concomitant use of Chemists' Own Sinus and Nasal Decongestant with other sympathomimetic amines or tricyclic antidepressants may cause a rise in blood pressure or hypertensive crisis. It should not be given to patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days after ceasing treatment with MAOIs (see Section 4.3 Contraindications).
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants - may cause an increase in blood pressure and additive effects.
When administered with pseudoephedrine the antibacterial agent, furazolidone, is known to cause a dose related inhibition of monoamine oxidase. Although there are no reports of hypotensive action caused by the concurrent administration of Chemists' Own Sinus and Nasal Decongestant and furazolidone, they should not be taken together.
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)
Safety for use of Chemists' Own Sinus and Nasal Decongestant during pregnancy has not yet been established.
Category B2 Australian categorisation definition. 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 show no evidence of an increased occurrence of foetal damage.
Use in lactation. Small amounts of pseudoephedrine are excreted into breast milk, and use is not recommended while breastfeeding.

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)

May cause sleeplessness if taken up to several hours before going to bed in sensitive people.
Adverse effects include:
Cardiovascular stimulation. Elevated blood pressure, palpitations, tachycardia or arrhythmias.
CNS stimulation. Headache, restlessness, feeling jittery, insomnia, anxiety, euphoric mood, tremor and (rarely) hallucinations, nervousness, vertigo.
Sweating or flushing; psychomotor hyperactivity (in the paediatric population); skin rashes, dysuria and urinary retention; hypersensitivity.
Children and the elderly are more likely to experience adverse effects than other age groups.
Post-marketing data. Additional adverse drug reactions (ADRs) identified during post-marketing experience with pseudoephedrine are included in Table 1. The frequencies are provided according to the following convention:
Very common: ≥ 1/10; common: ≥ 1/100, < 1/10; uncommon ≥ 1/1,000, < 1/100; rare: ≥ 1/10,000, < 1/1,000; very rare < 1/10,000.
In Table 1, the ADRs are presented with ADR frequency categories estimated from spontaneous reporting rates where numerator represents total number of reported company AEs under given PT or medical concept and the denominator represents exposure data calculated from sales 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

Symptoms. May include mild anxiety, hypertension, palpitations, irritability, restlessness, convulsions and difficulty with micturition, urinary retention, hallucinations or shortness of breath.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Pseudoephedrine, a sympathomimetic agent is an orally effective nasal decongestant, which produces vasoconstriction of the mucosa of the upper respiratory tract and paranasal sinuses. It is about equipotent with ephedrine but has less unwanted cardiovascular or CNS effects.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

Absorption. Pseudoephedrine is readily absorbed from the gastrointestinal tract.
Distribution. Small amounts are distributed into breast milk.
Metabolism. Less than 1% is metabolised in the liver by N-demethylation to an inactive metabolite. Pseudoephedrine has a half-life of 4-8 hours; elimination is enhanced and half-life accordingly shorter in acid urine.
Excretion. 55-95% of the drug is excreted unchanged in the urine.

5.3 Preclinical Safety Data

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

6 Pharmaceutical Particulars

6.1 List of Excipients

Dextrates, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, hypromellose, macrogol 400, magnesium stearate and carnauba wax.
See Section 2 Qualitative and Quantitative Composition.

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 light.

6.5 Nature and Contents of Container

Blister pack 12 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

A white or off-white crystalline powder; odourless or almost odourless.
Chemical structure.

Chemical name: [S-(R*,R*)]-a-[1-(methylamino)ethyl] benzenemethanol hydrochloride.
Molecular formula: C₁₀H₁₅NO,HCl (MW: 201.70).
CAS number. 345-78-8.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist only medicine.

Date of First Approval

13 March 2003

Date of Revision

03 December 2025

Summary Table of Changes