Dimetapp Cough Cold & Flu Night Relief

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

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

Dostupné s:

Haleon New Zealand ULC

INN (Mezinárodní Name):

Chlorphenamine maleate 2 mg

Léková forma:

Liquid filled capsule

Složení:

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

Jednotky v balení:

Blister pack, 8 capsules

Třída:

Pharmacy only

Druh předpisu:

Restricted

Výrobce:

Kongo Chemical Co., Ltd

Terapeutické indikace:

Temporary relief from the symptoms of the common cold and flu

Přehled produktů:

Package - Contents - Shelf Life: Blister pack, - 8 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, - 24 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, - 48 capsules - 24 months from date of manufacture stored at or below 25°C

Datum autorizace:

2011-05-26

Charakteristika produktu

NEW ZEALAND DATA SHEET
DIMETAPP COUGH COLD & FLU NIGHT RELIEF
___________________________________________________________________________
Page 1 of 11
1 PRODUCT NAME
Dimetapp Cough Cold & Flu Night Relief Liquid Filled Capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each liquid capsule contains:
Paracetamol 300 mg, Phenylephrine hydrochloride 5 mg, Dextromethorphan
hydrobromide
monohydrate 10 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
For 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, dry
irritating coughs, stuffy, runny noses. It also contains 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:
Two (2) capsules should be taken orally with water at bedtime as
necessary.
Do not exceed 2 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 product
for more than 48
hours, except on medical advice.
Do not use in children under 12 years.
NEW ZEALAND DATA SHEET
DIMETAPP COUGH COLD & FLU NIGHT RELIEF
___________________________________________________________________________
Page 2 of 11
4.3
Contraindications
Dimetapp Cough Cold & Flu Night Relief Liquid Caps are contraindicated
for use in patients:
•
with known hypersensitivity to the active ingredients paracetamol,
phenylephrine
hydrochloride, dextromethorphan hydrobromide monohydrate or
chlorphenamine
maleate or substances of similar chemical structure or any other
ingredient in the
product
•
taking prescription medication for depression, psychiatric