Dimetapp Cough Cold & Flu Decongestant Day & Night

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Dextromethorphan hydrobromide monohydrate 10mg;  ; Paracetamol 300mg; Phenylephrine hydrochloride 5mg; Chlorphenamine maleate 2mg; Dextromethorphan hydrobromide monohydrate 10mg; Paracetamol 300mg; Phenylephrine hydrochloride 5mg

Tilgængelig fra:

Haleon New Zealand ULC

INN (International Name):

Dextromethorphan hydrobromide monohydrate 10 mg

Lægemiddelform:

Liquid filled capsule

Sammensætning:

Active: Dextromethorphan hydrobromide monohydrate 10mg   Paracetamol 300mg Phenylephrine hydrochloride 5mg Excipient: Gelatin Macrogol 400 Opacode white NSP-78-18022 Plasticizer A-810 Povidone Propylene glycol Purified water Sodium metabisulfite Sunset yellow FCF Active: Chlorphenamine maleate 2mg Dextromethorphan hydrobromide monohydrate 10mg Paracetamol 300mg Phenylephrine hydrochloride 5mg Excipient: Brilliant blue FCF Gelatin Macrogol 400 Opacode white NSP-78-18022 Plasticizer A-810 Povidone Propylene glycol Purified water Quinoline yellow Sodium metabisulfite

Enheder i pakken:

Blister pack, 18 day and 6 night, 24 capsules

Klasse:

Pharmacy only

Recept type:

Restricted

Fremstillet af:

Wockhardt Ltd

Terapeutiske indikationer:

Temporary relief from the symptoms of the common cold and flu

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, 18 day and 6 night - 24 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, 36 day and 12 night - 48 capsules - 24 months from date of manufacture stored at or below 25°C

Autorisation dato:

2011-05-26

Produktets egenskaber

NEW ZEALAND DATA SHEET
DIMETAPP COUGH COLD & FLU DECONGESTANT DAY & NIGHT
___________________________________________________________________________
Page 1 of 12
1 PRODUCT NAME
Dimetapp Cough Cold & Flu Decongestant Day & Night Liquid Filled
Capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Day Liquid Capsule Contains:
Paracetamol 300 mg, Dextromethorphan hydrobromide monohydrate 10 mg,
Phenylephrine
hydrochloride 5 mg
Each Night Liquid Capsule Contains:
Paracetamol 300 mg, Dextromethorphan hydrobromide monohydrate 10 mg,
Phenylephrine
hydrochloride 5 mg, Chlorphenamine maleate 2 mg
Excipient(s) with known effect:
•
Sorbitol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Liquid filled capsule
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
The daytime capsules provide temporary relief from the symptoms of the
common cold and
flu such as nasal congestion, headaches, muscular aches, fever, body
aches and pains, sore
throat, stuffy, runny noses and dry irritating coughs.
The night time capsule also provides temporary relief from the major
symptoms of cold and
flu and also contain an antihistamine to relieve runny nose, sneezing,
itching of the nose and
throat, itchy watery eyes due to cold and flu symptoms, and therefore
allows a good night’s
sleep.
4.2
Dose and method of administration
Adults and children 12 years and over:
Day: Two (2) orange capsules should be taken orally with water, every
4-6 hours (Morning,
midday & afternoon) as necessary.
Night: Two (2) green capsules should be taken orally with water at
bedtime as necessary.
Allow 4- 6 hours between each dose.
NEW ZEALAND DATA SHEET
DIMETAPP COUGH COLD & FLU DECONGESTANT DAY & NIGHT
___________________________________________________________________________
Page 2 of 12
Do not exceed 6 orange day liquid capsules and 2 green night liquid
capsules in 24 hours.
Adults should not take this product for more than a few days at a time
except on medical
advice.
Children and adolescents 12 years and over should not use this pro