ROBITUSSIN DRY COUGH MEDICINE
Active substance: DEXTROMETHORPHAN HYDROBROMIDE
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PAA026827
Dry Cough Medicine
Liquid For Oral Administration Dextromethorphan Hydrobromide 7.5mg Per 5ml
Read all of this leaflet carefully because it contains important information for you This medicine is available without prescription. However, you will still need to use this medicine carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - You must contact a doctor if your symptoms worsen or do not improve after 7 days. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Robitussin Dry Cough Medicine is and what it is used for 2. Before you take Robitussin Dry Cough Medicine 3. How to take Robitussin Dry Cough Medicine 4. Possible side effects 5. How to store Robitussin Dry Cough Medicine 6. Further information 1. What Robitussin Dry Cough Medicine is and what it is used for Every 5ml of this medicine contains 7.5mg of the active ingredient dextromethorphan hydrobromide. This active ingredient belongs to a group of medicines called cough suppressants that work by providing relief from persistent dry irritant coughs. 2. Before you take Robitussin Dry Cough Medicine Do not take this medicine if: - You are allergic (hypersensitive) to dextromethorphan hydrobromide or any of the other ingredients in this medicine. Take special care and talk to your doctor before taking this medicine if: - You have had a cough for a long time or if you have asthma or suffer from serious asthma attacks, or if your cough is accompanied by a fever, rash, or persistent headache. - You have liver problems. Pregnancy and Lactation Talk to your doctor before taking this medicine if you are pregnant or breastfeeding. Taking other medicines Do not take if you are: - Taking a prescription monoamine oxidase inhibitor (MAOI) or have done so in the last 14 days. Talk to your doctor or pharmacist if you are: - Taking Quinidine or Amiodarone. Important information about some of the ingredients of this medicine: - This medicine contains amaranth (E123), which may cause allergic reactions. - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains Sorbitol and Maltitol. - This medicinal product contains 2.5 % v/v alcohol (ethanol) (196 mg per dose). This is equivalent to approximately 2 ml wine per dose which can be harmful for those suffering from alcoholism and should be taken into account if you are pregnant or breast-feeding or have liver disease or epilepsy. 3. How to take Robitussin Dry Cough Medicine For oral administration. Adults, the elderly and children over 12 years: Take 10ml up to four times daily, as required. Children under 12 years: Do not use. Do not exceed the stated dose. Stop use and ask a healthcare professional if your cough lasts for more than 7 days, or comes back. If you take more medicine than you should If you take too much of this medicine, consult your doctor or hospital immediately. Bring any remaining medicine to show the doctor.
4. Possible side effects Like all medicines, Robitussin Dry Cough Medicine can cause side effects, although not everybody gets them. Side effects with dextromethorphan hydrobromide are rare. However, susceptible individuals may experience unwanted side effects. If any of the side effects gets serious or you experience any other side effects, STOP taking this medicine immediately and consult your doctor: - Allergic reactions. Symptoms could include itchy skin or rashes, difficulty breathing, faster heart rate, swelling of the face or the throat. - Stomach upset. - Dizziness. 5. How to store Robitussin Dry Cough Medicine - Do not use this medicine after the expiry date shown on the end of the carton. - Store below 25C. - Keep out of the sight and reach of children. 6. Further information What Robitussin Dry Cough contains: Each 5ml contains 7.5mg of the active substance dextromethorphan hydrobromide. This medicine also contains: Glycerol, sodium carboxymethyl cellulose, sodium benzoate, disodium edetate, maltitol (E965), ethanol, citric acid anhydrous, amaranth (E123), caramel (E150), levomenthol, cherry/grenadine flavour, sorbitol solution 70%, sodium cyclamate, acesulfame potassium salt, purified water. Robitussin Dry Cough Medicine is supplied in a 100ml or 250ml bottle. Who makes and supplies this medicine: The Marketing Authorisation holder for your medicine is: Pfizer Consumer Healthcare Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. The dosing cup is manufactured by: Humphrey Cosburn Plastics, 89 Union Street, Toronto, Ontario, M6N 3N2, Canada The EU Authorised Representative is: Pfizer Consumer Healthcare Ltd This medicine is manufactured by: John Wyeth and Brother Limited, New Lane, Havant, Hampshire, PO9 2NG, United Kingdom. Or Wyeth Lederle S.p.A. Via Nettunese 90, 04011 Aprilia (LT) Italy. If you have any queries, comments about this medicine or require information in large print, tape or CD please contact the Careline by phone or write to: Careline, Pfizer Consumer Healthcare Ltd, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, UK. or carelineUK@pfizer.com
PL Number: 00165/0100 MA111/00402 Leaflet prepared: January 2012
* Trade Mark
PAA026827
Dry Cough Medicine
Liquid For Oral Administration Dextromethorphan Hydrobromide 7.5mg Per 5ml
Read all of this leaflet carefully because it contains important information for you This medicine is available without prescription. However, you will still need to use this medicine carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - You must contact a doctor if your symptoms worsen or do not improve after 7 days. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Robitussin Dry Cough Medicine is and what it is used for 2. Before you take Robitussin Dry Cough Medicine 3. How to take Robitussin Dry Cough Medicine 4. Possible side effects 5. How to store Robitussin Dry Cough Medicine 6. Further information 1. What Robitussin Dry Cough Medicine is and what it is used for Every 5ml of this medicine contains 7.5mg of the active ingredient dextromethorphan hydrobromide. This active ingredient belongs to a group of medicines called cough suppressants that work by providing relief from persistent dry irritant coughs. 2. Before you take Robitussin Dry Cough Medicine Do not take this medicine if: - You are allergic (hypersensitive) to dextromethorphan hydrobromide or any of the other ingredients in this medicine. Take special care and talk to your doctor before taking this medicine if: - You have had a cough for a long time or if you have asthma or suffer from serious asthma attacks, or if your cough is accompanied by a fever, rash, or persistent headache. - You have liver problems. Pregnancy and Lactation Talk to your doctor before taking this medicine if you are pregnant or breastfeeding. Taking other medicines Do not take if you are: - Taking a prescription monoamine oxidase inhibitor (MAOI) or have done so in the last 14 days. Talk to your doctor or pharmacist if you are: - Taking Quinidine or Amiodarone. Important information about some of the ingredients of this medicine: - This medicine contains amaranth (E123), which may cause allergic reactions. - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains Sorbitol and Maltitol. - This medicinal product contains 2.5 % v/v alcohol (ethanol) (196 mg per dose). This is equivalent to approximately 2 ml wine per dose which can be harmful for those suffering from alcoholism and should be taken into account if you are pregnant or breast-feeding or have liver disease or epilepsy. 3. How to take Robitussin Dry Cough Medicine For oral administration. Adults, the elderly and children over 12 years: Take 10ml up to four times daily, as required. Children under 12 years: Do not use. Do not exceed the stated dose. Stop use and ask a healthcare professional if your cough lasts for more than 7 days, or comes back. If you take more medicine than you should If you take too much of this medicine, consult your doctor or hospital immediately. Bring any remaining medicine to show the doctor.
4. Possible side effects Like all medicines, Robitussin Dry Cough Medicine can cause side effects, although not everybody gets them. Side effects with dextromethorphan hydrobromide are rare. However, susceptible individuals may experience unwanted side effects. If any of the side effects gets serious or you experience any other side effects, STOP taking this medicine immediately and consult your doctor: - Allergic reactions. Symptoms could include itchy skin or rashes, difficulty breathing, faster heart rate, swelling of the face or the throat. - Stomach upset. - Dizziness. 5. How to store Robitussin Dry Cough Medicine - Do not use this medicine after the expiry date shown on the end of the carton. - Store below 25C. - Keep out of the sight and reach of children. 6. Further information What Robitussin Dry Cough contains: Each 5ml contains 7.5mg of the active substance dextromethorphan hydrobromide. This medicine also contains: Glycerol, sodium carboxymethyl cellulose, sodium benzoate, disodium edetate, maltitol (E965), ethanol, citric acid anhydrous, amaranth (E123), caramel (E150), levomenthol, cherry/grenadine flavour, sorbitol solution 70%, sodium cyclamate, acesulfame potassium salt, purified water. Robitussin Dry Cough Medicine is supplied in a 100ml or 250ml bottle. Who makes and supplies this medicine: The Marketing Authorisation holder for your medicine is: Pfizer Consumer Healthcare Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. The dosing cup is manufactured by: Humphrey Cosburn Plastics, 89 Union Street, Toronto, Ontario, M6N 3N2, Canada The EU Authorised Representative is: Pfizer Consumer Healthcare Ltd This medicine is manufactured by: John Wyeth and Brother Limited, New Lane, Havant, Hampshire, PO9 2NG, United Kingdom. Or Wyeth Lederle S.p.A. Via Nettunese 90, 04011 Aprilia (LT) Italy. If you have any queries, comments about this medicine or require information in large print, tape or CD please contact the Careline by phone or write to: Careline, Pfizer Consumer Healthcare Ltd, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, UK. or carelineUK@pfizer.com
PL Number: 00165/0100 MA111/00402 Leaflet prepared: January 2012
* Trade Mark
PAA026827
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
