Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diphenhydramine hydrochloride; Dextromethorphan hydrobromide
Thornton & Ross Ltd
R05DA20
Diphenhydramine hydrochloride; Dextromethorphan hydrobromide
2mg/1ml ; 1.33mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03090200; GTIN: 5011309434217
IMPORTANT: PEEL HERE & READ ALL TEXT INSIDE BEFORE USE. Do not store above 25°C. Protect from light. MA HOLDER AND MANUFACTURER Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK PL 00240/0364 24920101 P1 P2 24920101 150ML 24920101 P TURN OVER P3 COVONIA HOT DOSE COUGH & COLD SYRUP is for night time relief of the symptoms of dry coughs and congestion from colds. SHAKE THE BOTTLE. Take the solution by mouth. ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS: Take at bedtime. Measure 15ml into a beaker and add about 15ml of hot (not boiling) water. Stir. Sip all the liquid within 10 minutes for full effect. Repeat after 6 hours if required. DO NOT GIVE TO CHILDREN UNDER 12 YEARS OLD. DO NOT EXCEED THE STATED DOSE. DO NOT TAKE WITH ANY OTHER COUGH AND COLD MEDICINE. AVOID ALCOHOLIC DRINK. PEEL WHERE SHOWN FOR FURTHER PRECAUTIONS. If symptoms persist consult your doctor. This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. ACTIVE INGREDIENTS PER 15ML: dextromethorphan hydrobromide 20mg, diphenhydramine hydrochloride 30mg. ALSO CONTAINS: ethanol, glycerol (E422), sorbitol (E420), sodium benzoate, maltitol liquid, propylene glycol. Alcohol 7.3 vol%. SEE REVERSE FOR FULL LIST. This medicine contains dextromethorphan which reduces the desire to cough and diphenhydramine (an antihistamine) which dries up your runny nose and relieves congestion. 1. BEFORE YOU USE THIS MEDICINE DO NOT USE THE MEDICINE IF YOU HAVE…. • An ALLERGY to any of the ingredients listed in section 3 • Taken MAOIS (MONOAMINE OXIDASE INHIBITORS) for depression within the last two weeks or are taking SSRIs for depression • SHORTAGE OF BREATH • LIVER PROBLEMS • PORPHYRIA • ASTHMA or a COUGH which produces PHLEGM. TALK TO YOUR DOCTOR IF YOU HAVE…. • Glaucoma • Difficulty passing urine • Prostate trouble • A blocked intestine • Epilepsy • Heart problems • A cough which lasts a Read the complete document
OBJECT 1 COVONIA HOT DOSE COUGH & COLD SYRUP Summary of Product Characteristics Updated 01-Dec-2016 | Thornton & Ross Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Covonia Hot Dose Cough & Cold Syrup 2. Qualitative and quantitative composition Dextromethorphan Hydrobromide Ph.Eur. Diphenhydramine Hydrochloride Ph.Eur. 6.65mg/5ml dose. 10.0mg/5ml dose. Excipients: Each 5ml contains Liquid Maltitol 1.125g, Ethanol (Alcohol) 7.3 vol % For a full list of excipients see section 6.1 3. Pharmaceutical form Oral Syrup 4. Clinical particulars 4.1 Therapeutic indications For the night time symptomatic relief of unproductive cough and congestive symptoms associated with colds. 4.2 Posology and method of administration Posology Adults, the Elderly and Children over 12 years One 15ml dose at bedtime, diluted with an equal amount of hot (not boiling) water. Sip all the liquid within 10 minutes of being diluted. Repeat after 6 hours if required. Children under 12 years Do not give to childr Read the complete document