Consumer medicine information

Robitussin Chesty Cough & Nasal Congestion Ps Oral Liquid

Guaifenesin; Pseudoephedrine hydrochloride

BRAND INFORMATION

Brand name

Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid

Active ingredient

Guaifenesin; Pseudoephedrine hydrochloride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Robitussin Chesty Cough & Nasal Congestion Ps Oral Liquid.

What is in this leaflet

This leaflet answers some common questions about Robitussin Chesty Cough & Nasal Congestion PS. It does not contain all the available information.

All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking Robitussin Chesty Cough & Nasal Congestion PS against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your pharmacist or doctor.

It does not take the place of talking to your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What is Robitussin Chesty Cough & Nasal Congestion PS used for

Relief from symptoms of chesty cough and cold: helps loosen phlegm and thin bronchial secretions to make coughs more productive and provides symptomatic relief from nasal, chest and sinus congestion due to common cold.

It contains the decongestant action of pseudoephedrine hydrochloride, which helps reduce nasal and sinus congestion making breathing easier. It also contains Guaiphenesin, an expectorant that helps to loosen chest congestion and break up a cough.

Ask your pharmacist or doctor if you have any questions about this medicine.

Before you take Robitussin Chesty Cough & Nasal Congestion PS

When you must not take it

Do not take Robitussin Chesty Cough & Nasal Congestion PS if you have an allergy to:

  • any medicine containing pseudoephedrine or guaiphenesin
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take Robitussin Chesty Cough & Nasal Congestion PS if you have:

  • very high blood pressure
  • severe coronary artery disease (heart disease caused by poor blood flow or narrowing of the blood vessels of the heart)
  • taken monoamine oxidase inhibitors, medicines used to treat depression, in the last 14 days

Do not use in children under 6 years of age

Do not take this medicine if you are pregnant or plan to become pregnant. It may affect your developing baby if you take it during pregnancy. Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

Stop use and ask a doctor if cough lasts for more than one week, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor

Before you start to take it

Tell your doctor before use if:

  1. you have any allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes, or ingredients listed at the end of this leaflet.
  1. you have or had any medical conditions, especially the following:
  • thyroid disease
  • depression
  • diabetes
  • high blood pressure
  • heart disease
  • asthma
  • glaucoma (high pressure in the eyes)
  • trouble urinating due to an enlarged prostate gland
  • porphyria, a rare blood pigment disorder
  • bronchitis
  • chronic obstructive pulmonary disease (COPD)
  • emphysema
  • smoker's cough
  • liver or kidney disease

This medicine may make your cough worse.

  1. Ask your pharmacist or doctor about taking Robitussin Chesty Cough & Nasal Congestion PS if you are breastfeeding.

If you are nursing a baby, small amounts of pseudoephedrine pass into the breast milk. Your pharmacist or doctor will discuss the potential benefits and risks of taking the medicine if you are breastfeeding.

If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking Robitussin Chesty Cough & Nasal Congestion PS.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Robitussin Chesty Cough & Nasal Congestion PS may interfere with each other.

In particular, you should tell your doctor or pharmacist if you are using:

  • medicines used to treat depression
  • medicines used to treat heart conditions
  • medicines used to treat high blood pressure
  • medicines used to treat urinary tract infections and bladder problems
  • medicines used to treat behavioural disorders
  • nasal decongestants from other cough, cold or allergy products
  • appetite suppressants

If you are using or in the last 2 weeks used:

  • Monoamine oxidase inhibitors, medicines used to treat depression or medicine for Parkinson's disease.

These medicines may be affected by Robitussin Chesty Cough & Nasal Congestion PS or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist has more information on medicines to be careful with or avoid whilst using Robitussin Chesty Cough & Nasal Congestion PS.

How to use Robitussin Chesty Cough & Nasal Congestion PS

Follow all directions given to you by your pharmacist or doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box/bottle, ask your pharmacist or doctor for help.

How much to use

Take orally every 4-6 hours when necessary.

Adults & children 12 years and over: 10 mL

Children 6 years to under 12 years: 5 mL

Do not exceed 4 doses in a 24 hour period.

Do not use in children under 6 years of age.

Use in children aged 6-11 years only on the advice of a doctor, pharmacist or nurse practitioner.

Do not exceed the recommended dosage

How long to take it

Do not take for more than a few days unless directed by a doctor

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Otherwise, take it as soon as you remember and then go back to using Robitussin Chesty Cough & Nasal Congestion PS as you would normally.

Do not use a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your pharmacist or doctor.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints

If you use too much (overdose)

Stop use and immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to the nearest hospital, if you think that you or anyone else may have used too much Robitussin Chesty Cough & Nasal Congestion PS. Do this even if there are no signs of discomfort or poisoning. Keep these telephone numbers handy.

While you are using Robitussin Chesty Cough & Nasal Congestion PS

Things you must do

Talk to your pharmacist or doctor if your symptoms do not improve. Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.

Stop use and ask a doctor if cough lasts for more than one week, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Things you must not do

Do not take Robitussin Chesty Cough & Nasal Congestion PS to treat any other complaints unless your pharmacist or doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not take more than the recommended dose unless your pharmacist or doctor tells you to.

Things to be careful of:

Do not drive or operate machinery until you know how Pseudoephedrine hydrochloride affects you. Robitussin Chesty Cough & Nasal Congestion PS may cause dizziness in some people and therefore may affect alertness.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well whilst using Robitussin Chesty Cough & Nasal Congestion PS.

Robitussin Chesty Cough & Nasal Congestion PS may have unwanted side effects in a few individuals. All medicines can have side effects. Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of using this medicine Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your pharmacist or doctor to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following side effects:

  • drowsiness
  • difficulty sleeping
  • nervousness
  • excitability
  • restlessness
  • dizziness
  • fear or anxiety
  • rapid heart beat
  • tremor
  • hallucinations
  • nausea or vomiting
  • stomach pain
  • rash
  • diarrhoea
  • headache
  • urticaria

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Children and people over 65 years of age may have an increased chance of getting side effects.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • urine retention
  • rectal bleeding
  • shortness of breath
  • wheezing or difficulty breathing
  • sudden abdominal pain
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your pharmacist or doctor if you notice anything that is making you feel unwell.

Some individuals may experience other side effects while using Robitussin Chesty Cough & Nasal Congestion PS.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Robitussin Chesty Cough & Nasal Congestion PS

Storage

Keep Robitussin Chesty Cough & Nasal Congestion PS in a cool dry place where the temperature stays below 25°C. Do not refrigerate.

Do not store in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

After the expiry date has passed, any unused Robitussin Chesty Cough & Nasal Congestion PS should be returned to your pharmacist so that it can be disposed of safely.

Product Description

What it looks like

Robitussin Chesty Cough & Nasal Congestion PS is clear red coloured syrup with a cherry odour.

Ingredients

Each 10mL of Robitussin Chesty Cough & Nasal Congestion PS contains:

Pseudoephedrine Hydrochloride 60mg.

Guaiphenesin 200mg

Robitussin Chesty Cough & Nasal Congestion PS also contains: Ethanol (3.8% v/v), Cherry Pistachio, Citric Acid-Anhydrous, Allura Red AC, Glycerol, Menthol, Propylene Glycol, Raspberry Superarome, Saccharin Sodium, Sodium Benzoate, Sorbitol Solution (70%crystallizing) and Water-Purified.

Supplier

Pfizer Australia Pty Limited
Level 17, 151 Clarence Street,
Sydney, New South Wales, 2000
Australia

Robitussin Chesty Cough & Nasal Congestion PS - AUST R 13885

Date of Preparation: July 2005

Date of Revision: 29 May 2019.

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid

Active ingredient

Guaifenesin; Pseudoephedrine hydrochloride

Schedule

S3

 

1 Name of Medicine

Guaifenesin, pseudoephedrine hydrochloride.

6.7 Physicochemical Properties

Guaifenesin is chemically known as (2RS)-3-(2-Methoxyphenoxy)propane-1,2-diol. It has a molecular formula of C10H14O4 and molecular weight of 198.2.
Guaifenesin is a white or almost white, crystalline powder, that is sparingly soluble in water and soluble in alcohol.
Pseudoephedrine hydrochloride is chemically known as (1S,2S)-2-(Methylamino)-1-phenylpropan-1-ol hydrochloride. It has a molecular formula of C10H16ClNO and molecular weight of 201.7.
Pseudoephedrine hydrochloride is a white, crystalline powder or colourless crystals, freely soluble in water and in alcohol, and sparingly soluble in methylene chloride.

Chemical structure.


CAS number.

Guaifenesin: 93-14-1.
Pseudoephedrine hydrochloride: 345-78-8.

2 Qualitative and Quantitative Composition

Each 10 mL of Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid contains guaifenesin 200 mg and pseudoephedrine hydrochloride 60 mg.

Excipients with known effects.

Ethanol, saccharin sodium, sodium benzoate, sorbitol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Oral liquid.
Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid is a clear, red coloured syrup with a cherry odour.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Guaifenesin is an expectorant, which clears chest congestion by loosening and reducing the viscosity of phlegm, increasing the volume of phlegm and making coughs more productive.
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

Guaifenesin is well absorbed from the gastrointestinal tract. It is metabolised primarily to Beta-2-methoxyphenoxy-lactic acid and then excreted in the urine. In a study where subjects were given 400 mg of guaifenesin orally, no unchanged drug could be detected in the urine. The plasma half-life of guaifenesin is one hour.
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 acidic urine. Small amounts are distributed into breast milk.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Relief from symptoms of chesty cough and cold; helps loosen phlegm and thin bronchial secretions to make coughs more productive (expectorant) and provides symptomatic relief from nasal, chest and sinus congestion due to common cold.

4.3 Contraindications

Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid is contraindicated for use in patients:
with known hypersensitivity or idiosyncratic reaction to guaifenesin, pseudoephedrine or any of the other ingredients in the product;
with severe hypertension or coronary artery disease;
taking monoamine oxidase inhibitors (MAOIs) or who have been taking the MAOI within the last 14 days;
under 6 years of age.

4.4 Special Warnings and Precautions for Use

Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid should be used with caution in patients with hypertension, hyperthyroidism, diabetes mellitus, coronary heart disease, ischaemic heart disease, glaucoma, prostatic hypertrophy, severe hepatic or renal dysfunction, porphyria, as guaifenesin is possibly porphyrogenic.
Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid should not be used in patients with chronic or persistent cough associated with chronic lower respiratory tract diseases such as asthma, bronchitis, chronic obstructive pulmonary disease (COPD), emphysema or smoker's cough or cough associated with excessive secretions.
Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid should not be taken for longer than a few days.
Pseudoephedrine may cause sleeplessness if it is taken up to several hours before going to bed.
Patients should not exceed the recommended dosage.
This product should be kept out of reach of children.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.
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.

Use in hepatic impairment.

This product should be used in caution in patients with impaired hepatic function.

Use in renal impairment.

This product should be used in caution in patients with impaired renal function.

Use in the elderly.

See Section 4.8 Adverse Effects (Undesirable Effects).

Paediatric use.

See Section 4.8 Adverse Effects (Undesirable Effects).

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are no reported interactions with other medicines and guaifenesin.
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 (see Section 4.3 Contraindications for further information).
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants may cause an increase in blood pressure and additive effects.
Antihypertensive medication, e.g. 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.
(Category B2)
Drugs which have been taken by only a limited number of pregnant women or women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate, or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Safety in pregnancy has not been established, therefore Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid should not be used in pregnant women, or those likely to become pregnant, unless the expected benefit outweighs any potential risk.
It is not known whether guaifenesin is excreted in breast milk or whether it has a harmful effect on the breastfeeding infant. Small amounts of pseudoephedrine are excreted in breast milk, but the effect on breastfed infants is unknown. Therefore it is not recommended for breastfeeding mothers unless the expected benefits outweigh any potential risk.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions may be associated with the use of guaifenesin/pseudoephedrine containing products.

Cardiac disorders.

Palpitation, tachycardia or arrhythmias.

Gastrointestinal disorders.

Nausea, vomiting, diarrhoea, stomach pain, ischaemic colitis (frequency unknown).

Immune system disorders.

Hypersensitivity reactions.

Nervous system disorders.

Dizziness, headache, drowsiness, psychomotor hyperactivity.

Psychiatric disorders.

Agitation, anxiety, excitability, insomnia, irritability, nervousness, restlessness, tremors and (rarely) hallucinations.

Renal and urinary disorders.

Urinary retention.

Skin and subcutaneous tissue disorders.

Rash, urticaria.

Vascular disorders.

Hypertension, increased blood pressure.
Children and the elderly are more likely to experience adverse effects than other age groups.

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.

4.2 Dose and Method of Administration

Dosage.

Every 4 to 6 hours orally when necessary.

Adults and children 12 years and over.

10 mL.

Children 6 years to under 12 years.

5 mL.
Do not exceed 4 doses in 24 hours.
Do not use in children under 6 years of age. Use in children aged 6-11 years only on the advice of a doctor, pharmacist or nurse practitioner.
Do not use in children under 6 years.

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.

4.9 Overdose

Symptoms which may be associated with high doses (overdosage) of guaifenesin/pseudoephedrine:

Cardiac disorders.

Bradycardia, palpitation, tachycardia.

Gastrointestinal disorders.

Vomiting, nausea, diarrhoea and stomach pain.

Nervous system disorders.

Convulsion, dizziness, tremor, headache and drowsiness.

Psychiatric disorders.

Agitation, anxiety, insomnia, irritability, restlessness, nervousness.

Skin disorders.

Rash.

Vascular disorders.

Hypertension, increased blood pressure.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S3.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ethanol (3.8% v/v), cherry pistachio, citric acid, allura red AC, glycerol, menthol, propylene glycol, raspberry superarome, saccharin sodium, sodium benzoate, sorbitol solution (70% crystallizing) and purified water.

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 25°C. Do not refrigerate.

6.5 Nature and Contents of Container

Robitussin Chesty Cough & Nasal Congestion PS Oral Liquid is packed in bottles.

Pack sizes.

100 mL: currently marketed.
25 mL: professional sample.

6.6 Special Precautions for Disposal

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

Summary Table of Changes