Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
paracetamol, Quantity: 500 mg; pseudoephedrine hydrochloride, Quantity: 30 mg; chlorphenamine maleate, Quantity: 2 mg
Aspen Pharma Pty Ltd
chlorphenamine maleate,dextromethorphan hydrobromide monohydrate,Paracetamol,Pseudoephedrine hydrochloride
Tablet, film coated
Excipient Ingredients: hydrogenated vegetable oil; croscarmellose sodium; pregelatinised maize starch; Carnauba Wax; magnesium stearate; microcrystalline cellulose; povidone; titanium dioxide; indigo carmine; hyprolose; iron oxide red; iron oxide black
Oral
6 night tablets, 18 day tablets
(S3) Pharmacist Only Medicine
Provides fast and effective relief from the symptoms of cold and flu. The non-drowsy Day tablet temporarily relieves: blocked noses, runny noses, nagging cough, headaches, body aches and pains, and fever. The Night tablet contains an antihistamine and temporarily relieves: blocked noses, headaches, body aches and pains, and fever.
Visual Identification: Pale blue film coated round plain tablet with a break bar; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-08-30
Chemists’ Own Cough, Cold & Flu Day /Night Tablets - CMI Page 1 of 4 CHEMISTS’ OWN COUGH, COLD & FLU DAY/NIGHT TABLETS _Pseudoephedrine hydrochloride _ _Paracetamol _ _Dextromethorphan hydrobromide monohydrate _ _Chlorphenamine maleate _ ____________________________________________________________________________________________ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Chemists’ Own Cough, Cold & Flu Day /Night Tablets. It does not contain all of the available information about Chemists’ Own Cough, Cold & Flu Day/Night Tablets. It does not replace talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Chemists’ Own Cough, Cold & Flu Day/Night Tablets against the benefits he or she expects it will have. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ARE CHEMISTS’ OWN COUGH, COLD & FLU DAY/NIGHT TABLETS The name of your medicine is Chemists’ Own Cough, Cold & Flu Day/Night Tablets. The active ingredients in the day tablet are pseudoephedrine hydrochloride, paracetamol and dextromethorphan hydrobromide monohydrate. _ _ The active ingredients in the night tablet are pseudoephedrine hydrochloride, paracetamol and chlorphenamine maleate. Chemists’ Own Cough, Cold & Flu Day/Night Tablets_ _ belong to a group of medicines for the treatment of symptoms of colds and flu. Pseudoephedrine hydrochloride_ _ relieves blocked nose and sinuses. Paracetamol relieves pain and reduces fever. Dextromethorphan hydrobromide monohydrate suppresses coughing. Chlorphenamine maleate relieves symptoms of allergies including blocked nose and sinuses. WHAT CHEMISTS’ OWN COUGH, COLD & FLU DAY/NIGHT TABLETS ARE USED FOR Chemists’ Own Cough, Cold & Flu Day/Night tablets_ _ belong to a group of medicines for the treatment of symptoms of colds and flu. Your doctor or pha read_full_document
1 AUSTRALIAN PRODUCT INFORMATION – CHEMISTS’ OWN COUGH, COLD & FLU DAY/NIGHT (PSEUDOEPHEDRINE HYDROCHLORIDE + PARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE & CHLORPHENAMINE MALEATE + PSEUDOEPHEDRINE HYDROCHLORIDE + PARACETAMOL) TABLETS 1 NAME OF THE MEDICINE Day Tablets: pseudoephedrine hydrochloride + paracetamol + dextromethorphan hydrobromide monohydrate Night Tablets: chlorphenamine maleate + pseudoephedrine hydrochloride + paracetamol. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each day tablet contains the active ingredients: Paracetamol 500 mg, Pseudoephedrine hydrochloride 30 mg and Dextromethorphan hydrobromide monohydrate 15 mg. Each night-time tablet contains the active ingredients: Paracetamol 500 mg, Pseudoephedrine hydrochloride 30 mg and Chlorphenamine maleate 2 mg. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Day tablet: Pale yellow film coated round plain tablet with a break bar on one side. Night tablet: Pale blue film coated round plain tablet with a break bar on one side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Provides fast and effective relief from the symptoms of cold and flu. The non-drowsy “DAY” tablet temporarily relieves blocked noses, runny noses, nagging cough, headaches, body aches, pains, and fever. The “NIGHT” tablet contains an antihistamine and temporarily relieves blocked noses, headaches, body aches, pains, and fever. 2 4.2 D OSE AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN 12 YEARS AND OVER: Daytime: One to two pale yellow ‘DAY’ tablets in the morning, at midday and again in the afternoon. Night-time: Take one to two pale blue ‘NIGHT’ tablets at bedtime. Maximum of 8 tablets in 24 hours. Duration of use: Chemists’ Own Cough, Cold & Flu Day/Night Tablets should not be taken for more than 48 hours except on medical advice. 4.3 C ONTRAINDICATIONS Chemists’ Own Cough, Cold & Flu Day & Night Tablets are contraindicated in patients: • With known sensitivity to paracetamol, pseudoephedrin read_full_document