Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Brompheniramine maleate 0.4 mg/mL; ; Dextromethorphan hydrobromide monohydrate 2 mg/mL; ; ; Phenylephrine hydrochloride 1 mg/mL;
Haleon New Zealand ULC
Brompheniramine maleate 0.4 mg/mL
Elixir
Active: Brompheniramine maleate 0.4 mg/mL Dextromethorphan hydrobromide monohydrate 2 mg/mL Phenylephrine hydrochloride 1 mg/mL Excipient: Citric acid Ethanol Glycerol Grape flavour 11540 Grape flavour 5-8994 Propylene glycol Purified water Saccharin sodium Sodium benzoate Sorbitol
Bottle, glass, Amber, 25 mL
Pharmacy only
Restricted
Keshava Organics Pvt Ltd
Temporarily suppresses dry coughs and relieves common cold symptoms like nasal congestion, runny nose, sneezing and itchy, watery eyes.
Package - Contents - Shelf Life: Bottle, glass, Amber - 25 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, Amber, Sample pack - 45 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, Amber - 50 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
2002-04-18
NEW ZEALAND DATA SHEET DIMETAPP COUGH & COLD COLOUR FREE ___________________________________________________________________________ Page 1 of 9 1 PRODUCT NAME Dimetapp Cough & Cold Colour Free Elixir 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL of oral liquid contains: Brompheniramine maleate 2 mg, Phenylephrine hydrochloride 5 mg, Dextromethorphan hydrobromide monohydrate 10 mg. Excipient(s) with known effect: • Sodium benzoate • Sorbitol • Ethanol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Elixir 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Dimetapp Cough & Cold Colour Free temporarily suppresses dry coughs and relieves common cold symptoms like nasal congestion, runny nose, sneezing and itchy, watery eyes. 4.2 Dose and method of administration Children 6 to under 12 years: 5 mL Every 4 hours, as necessary Adults and children 12 years and over: 10 mL Every 4 hours, as necessary Do not exceed 6 doses in any 24 hour period. 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 Dimetapp Cough & Cold Colour Free is contraindicated for use in patients: • With known hypersensitivity to the active ingredients, brompheniramine maleate, phenylephrine hydrochloride and Dextromethorphan hydrobromide monohydrate or NEW ZEALAND DATA SHEET DIMETAPP COUGH & COLD COLOUR FREE ___________________________________________________________________________ Page 2 of 9 any other ingredient in the product • taking prescription medication for depression, psychiatric or emotional conditions e.g. a monoamine oxidase inhibitor (MAOI), selective serotonin reuptake inhibitor (SSRI) or Parkinson’s disease, or for 2 weeks after stopping the medication. If you are unsure if your prescription medication contains any of these drugs, ask a doctor or pharmacist before taking this product. • with severe hypertension or coronary artery disease • with narrow-angle glaucoma • wit Przeczytaj cały dokument