20 mg/ml Oral solution guaifenesin
WHAT THERACOUGH IS AND WHAT IT IS USED FOR
Theracough is used to treat coughs with sticky mucus.
Theracough is thought to dissolve the tough mucus in the airways, facilitate expectoration and relieve the cough.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days, or if the cough is accompanied by a high body temperature, rash, or persistent headache.
BEFORE YOU USE THERACOUGH
Do not use Theracough
If you are allergic to guaifenesin or any of the other ingredients of this medicine (listed in section 6).
Other medicines and Theracough
Theracough is not expected to affect or be affected by other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If you are pregnant, you should not use this medicine except on the advice of a doctor. If you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving ability and use of machinery
Theracough has no known effects on the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Theracough contains sorbitol and alcohol
Theracough contains 280 mg sorbitol per ml. Sorbitol is a source of fructose. If you (or your child) have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that makes it impossible to break down fructose, consult a doctor before using this medicine. Sorbitol can cause stomach/intestinal discomfort and can have a mild laxative effect.
Theracough oral solution contains 6.2 vol% ethanol (alcohol), i.e. up to 750 mg per dose (15 ml), corresponding to 18.6 ml of strong beer or 7.8 ml of wine per dose.
Harmful to people suffering from alcoholism. Attention should be paid to pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
HOW TO USE THERACOUGH
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults: 15 ml 2-3 times daily.
Children 8-14 years: 5-10 ml 2-3 times daily.
Children 4-8 years: 5 ml 2-3 times daily.
Children 2-3 years: 3 ml 2-3 times daily
To be swallowed only.
Do not exceed the recommended dose.
Do not use it for children under 2 years of age.
Do not use it for more than 7 days without talking to your doctor.
Do not use together with other medicines containing guaifenesin, to treat cough or cold.
Measure with the supplied graduated measuring cup. After use and before use by another person, rinse the dosing cup with water and dry it.
In the case of problems with the respiratory tract, advice from medical personnel should be sought if the symptoms do not improve quickly.
If you use too much Theracough
Symptoms of overdose may include nausea and lethargy.
If you have ingested too much medicine, or if e.g. a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Theracough
Do not take a double dose to make up for a missed dose.
If you have further questions about this medicine, contact your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Theracough can cause side effects, although not everybody gets them.
Stop using this medicine and contact your doctor immediately if you experience:
Allergic reactions, which can be serious, with signs such as:
- Raised and itchy rash (hives)
- Swelling (sometimes of the face, mouth, or throat, or causing difficulty breathing).
- Feeling faint, which may lead to loss of consciousness.
Other side effects:
Common ( affects more than 1 in 100 patients ): Vomiting
Less common ( affects less than 1 in 100 ): Gastrointestinal problems, e.g. abdominal pain
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
HOW TO STORE THERACOUGH
Store out of sight and reach of children.
Use before the expiry date stated on the carton after Expiration. dat. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
OTHER INFORMATION
Contents declaration
- The active substance is guaifenesin. 5 ml Theracough contains 100 mg guaifenesin.
- Other ingredients are ethanol, sorbitol 280 mg, glycerol, saccharin sodium, vanilla, and licorice flavoring, and purified water.
Appearance and package sizes of the medicine
200 ml glass bottle
Marketing Authorisation Holder:
GlaxoSmithKline Consumer Healthcare ApS
PO Box 61,
2610 Rødovre,
Denmark
Manufacturer:
GlaxoSmithKline Consumer Healthcare ApS
Delta Park 37
2665 Vallensbæk Strand, Denmark