Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Dextromethorphan hydrobromide monohydrate 3 mg/mL; ; ; Guaifenesin 20 mg/mL; ; Dextromethorphan hydrobromide monohydrate 3 mg/mL; Guaifenesin 20 mg/mL; Dextromethorphan hydrobromide monohydrate 3 mg/mL; Guaifenesin 20 mg/mL
Haleon New Zealand ULC
Dextromethorphan hydrobromide monohydrate 3 mg/mL
Oral solution
Active: Dextromethorphan hydrobromide monohydrate 3 mg/mL Guaifenesin 20 mg/mL Excipient: Allura red AC Cherry flavour (vanilla) 21146 Cherry flavour 119062 Citric acid Ethanol Lemon wonf S-2522 Glycerol Menthol Propylene glycol Purified water Saccharin sodium Sodium benzoate Sorbitol Sweet flavour 13540488 Vanilla flavour 52089A Active: Dextromethorphan hydrobromide monohydrate 3 mg/mL Guaifenesin 20 mg/mL Excipient: Allura red AC Cherry flavour (vanilla) 21146 Cherry flavour 119062 Citric acid Ethanol Glycerol Lemon Flavour 462924 Menthol Propylene glycol Purified water Saccharin sodium Sodium benzoate Sorbitol Sweet flavour 13540488 Vanilla flavour 52089A Active: Dextromethorphan hydrobromide monohydrate 3 mg/mL Guaifenesin 20 mg/mL Excipient: Allura red AC Cherry flavour (vanilla) 21146 Cherry flavour 119062 Citric acid Ethanol Glycerol Lemon Flavour 462924 Menthol Propylene glycol Purified water Saccharin sodium Sodium benzoate Sorbitol Sweet flavour SC822921 Vanilla flavour 52089A
Bottle, glass, amber, sample, 25 mL
Pharmacy only
Restricted
F Hoffmann-La Roche Ltd
For the temporary relief of cough and chest congestion due to cold and flu.
Package - Contents - Shelf Life: Bottle, glass, amber, sample - 25 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, amber, sample - 45 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, amber - 100 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, amber - 200 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, amber - 250 mL - 60 months from date of manufacture stored at or below 25°C
1994-10-12
CMI_ROBITUSSIN COUGH & CHEST CONGESTION ORAL SOLUTION_1 MAR 2011 1 ROBITUSSIN COUGH & CHEST CONGESTION ORAL LIQUID ____________________________________________________________________________ CONSUMER MEDICINE INFORMATION (FOR NEW ZEALAND) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Robitussin Cough & Congestion. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits . Your pharmacist or doctor has weighed the risks of you taking Robitussin Cough & Chest Congestion against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ROBITUSSIN COUGH & CHEST CONGESTION IS USED FOR Expectorant, cough suppressant_. _ For the temporary relief of cough and chest congestion due to cold and flu. Robitussin Cough & Chest Congestion combines the action of the expectorant guaiphenesin and the cough suppressant dextromethorphan Guaiphenesin is an expectorant that loosens and reduces the thickness of phlegm, making it easier to cough up Dextromethorphan is a cough suppressant that acts on the cough centre in the brain to suppress a dry cough. ASK YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT THIS MEDICINE. Your pharmacist or doctor may have given it for another reason. BEFORE YOU TAKE/GIVE ROBITUSSIN COUGH & CHEST CONGESTION _WHEN YOU MUST NOT TAKE IT _ DO NOT GIVE THIS MEDICINE TO: children under 6 years of age DO NOT TAKE ROBITUSSIN COUGH & CHEST CONGESTION IF YOU HAVE AN ALLERGY TO: any medicine containing guaiphenesin or dextromethorphan 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 Lue koko asiakirja
NEW ZEALAND DATA SHEET ROBITUSSIN COUGH AND CHEST CONGESTION ___________________________________________________________________________ Page 1 of 7 1 PRODUCT NAME Robitussin Cough & Chest Congestion Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of oral solution contains: Guaifenesin 20 mg, Dextromethorphan hydrobromide monohydrate 3 mg Excipient(s) with known effect: • Sodium benzoate • Sorbitol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Solution 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Robitussin Cough & Chest Congestion is an expectorant cough suppressant. For the temporary relief of cough and chest congestion due to cold and flu 4.2 Dose and method of administration Every 6 to 8 hours orally when necessary: Adults and Children 12 years and over: 10 mL Children 6 years – 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 to 11 years only on the advice of a doctor, pharmacist or nurse practitioner. 4.3 Contraindications Robitussin Cough & Chest Congestion is contraindicated for use in: • patients with known hypersensitivity or idiosyncratic reaction to Guaifenesin, Dextromethorphan hydrobromide monohydrate or any of the other ingredients in the product. • patients taking a prescription monoamine oxidase inhibitor (MAOI), a selective serotonin reuptake inhibitor (SSRI), or other medications for depression, psychiatric, or emotional conditions, or Parkinson's disease, or for 2 weeks after stopping the medication. If you are not sure if your prescription medication contains one of these drugs, ask a doctor or pharmacist before taking this product. NEW ZEALAND DATA SHEET ROBITUSSIN COUGH AND CHEST CONGESTION ___________________________________________________________________________ Page 2 of 7 • patients having an acute asthma attack • patients with impaired hepatic function • patients with respiratory insufficiency and respiratory depression • children under 6 Lue koko asiakirja