Coldrex Hot Remedy Cold & Flu Hot Lemon

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

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Produktets egenskaber Produktets egenskaber (SPC)
16-07-2012

Aktiv bestanddel:

Paracetamol 1000mg;  ;  ;  

Tilgængelig fra:

Haleon New Zealand ULC

INN (International Name):

Paracetamol 1000 mg

Dosering:

1000 mg

Lægemiddelform:

Powder for oral solution

Sammensætning:

Active: Paracetamol 1000mg       Excipient: Ascorbic acid Citric acid Colloidal silicon dioxide Lemon flavour 610399E Maize starch Maltodextrin Saccharin sodium Sodium citrate dihydrate Sodium cyclamate Sucrose Turmeric yellow

Enheder i pakken:

Sachet, laminate, Paper/PE/Al Foil/PE, 10 dose units

Klasse:

General sale

Recept type:

General sale

Fremstillet af:

Granules India Limited

Terapeutiske indikationer:

Fast, effective temporary relief from cold & flu symptoms such as headache, body aches & pain, sore throat. It also reduces fever.

Produkt oversigt:

Package - Contents - Shelf Life: Sachet, laminate, Paper/PE/Al Foil/PE - 10 dose units - 36 months from date of manufacture stored at or below 25°C

Autorisation dato:

2008-07-25

Produktets egenskaber

                                NEW ZEALAND DATASHEET 
COLDREX HOT REMEDY COLD & FLU HOT LEMON 
POWDER FOR ORAL SOLUTION 
Paracetamol (BP) 1000mg/sachet 
 
PRESENTATION 
Pale yellow, free flowing heterogeneous powder with and
odour of lemon 
INDICATIONS 
Fast, effective temporary relief from cold & flu symptoms such
as headache, 
body aches & pain, sore throat.  It also reduces fever. 
DOSAGE AND ADMINISTRATION 
ADULTS 
Adults and children aged 12 years and over:   
1 sachet every 6 hours as necessary.  Maximum 4 sachets in 24
hours. 
Empty contents of one sachet into a mug, half fill with
hot water and then stir 
well.  Add cold water as necessary and sugar if desired. 
Do not use for more than a few days at a time
in adults except on medical 
advice. 
Should not be used for more than 48
hours for children  12  –  17 except on 
medical advice. 
Do not exceed the stated dose. 
Should not be used with other paracetamol-containing products. 
Minimum dosing interval:  4 hours 
CHILDREN 
Not for use in children under the age of 12. 
RENAL AND HEPATIC IMPAIRMENT 
Patients who have been diagnosed with
liver or kidney impairment must seek 
medical advice before taking this medication. 
(See WARNINGS and 
PRECAUTIONS) 
CONTRAINDICATIONS 
Paracetamol is contraindicated in patients with a
previous history of 
hypersensitivity to paracetamol or any of the excipients. 
WARNINGS AND PRECAUTIONS 
Underlying liver disease increases the risk of paracetamol-related
liver 
damage.  Patients who have been diagnosed with
liver or kidney impairment 
must seek medical advice before taking this medication. 
Contains 3.735 g sucrose per sachet.  This should be taken
into account in 
patients with diabetes.  Patients with rare
hereditary problems of fructose 
intolerance, glucose-galactose malabsorption or sucrase-isomaltase 
insufficiency should not take this medi
                                
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