MIMS Revision Date: 01 February 2026

Notes

Sponsored by Kenvue Pacific Australia New Zealand

1 Name of Medicine

Pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Sudafed Sinus and Nasal Decongestant tablets contain pseudoephedrine hydrochloride 60 mg.
Sudafed Sinus and Nasal Decongestant also contains lactose. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sudafed Sinus and Nasal Decongestant tablets are white, biconvex, round and uncoated. They are embossed with 'S7A' and scored on the upper face, and the bottom face is plain.

4 Clinical Particulars

4.1 Therapeutic Indications

Sudafed Sinus and Nasal Decongestant provides symptomatic relief of sinus and nasal congestion due to allergic (seasonal) rhinitis, vasomotor (perennial) rhinitis, sinusitis, the common cold and flu.

4.2 Dose and Method of Administration

The recommended dose of Sudafed Sinus and Nasal Decongestant for adults and children 12 years and over is 1 tablet 3 to 4 times a day.
Sudafed Sinus and Nasal Decongestant should not be used for children under 12 years.
No more than 4 tablets should be taken in 24 hours.
Sudafed Sinus and Nasal Decongestant should not be used for more than 7 days except on medical advice.

4.3 Contraindications

Pseudoephedrine is contraindicated for use in patients:
with known hypersensitivity or idiosyncratic reaction to pseudoephedrine;
with known hypersensitivity or idiosyncratic reaction to any of the other ingredients in the product;
with severe or uncontrolled hypertension or severe coronary artery disease;
taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days;
with severe acute or chronic kidney disease/renal failure.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

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 used with caution in patients with: hypertension, hyperthyroidism, diabetes mellitus, coronary heart disease, ischaemic heart disease, glaucoma, prostatic hypertrophy.
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.
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. No data available.
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

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.
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, pseudoephedrine 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

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)

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;
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

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia). In New Zealand call 0800 764 766.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. 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. The safety of pseudoephedrine from clinical trial data is based on data from 6 randomized, placebo-controlled single dose clinical trials and 6 randomized, placebo-controlled multiple dose clinical trials for the treatment of nasal congestion with allergic rhinitis or common cold or prevention of sinus symptoms/ infection after a natural cold.
Table 2 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.

5.2 Pharmacokinetic Properties

Absorption. Pseudoephedrine is readily absorbed from the gastrointestinal tract.
Distribution. Small amounts are distributed into breast milk.
Metabolism. It has a half-life of about 5-8 hours; elimination is enhanced and half-life reduced accordingly in acid urine.
Excretion. It is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite.

5.3 Preclinical Safety Data

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

6 Pharmaceutical Particulars

6.1 List of Excipients

Sudafed Sinus and Nasal Decongestant contains lactose, magnesium stearate, povidone, maize starch.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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. Keep dry.

6.5 Nature and Contents of Container

Sudafed Sinus and Nasal Decongestant blister packs (PVC/PVDC) come in the following sizes: 4 tablets; 12 tablets^#.
^#Marketed.
AUST R 11003.

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.

CAS number. CAS Registry Number: 345-78-8.

7 Medicine Schedule (Poisons Standard)

Sudafed Sinus and Nasal Decongestant blister packs come in the following sizes:
4 tablets (S3) Pharmacist Only Medicine.
12 tablets^# (S3) Pharmacist Only Medicine.
^# Marketed.

Date of First Approval

01 May 2006

Date of Revision

28 November 2025

Summary Table of Changes