Coldrex Hot Remedy Cold & Flu Hot Lemon

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Paracetamol 1000mg;  ;  ;  

Available from:

Haleon New Zealand ULC

INN (International Name):

Paracetamol 1000 mg

Dosage:

1000 mg

Pharmaceutical form:

Powder for oral solution

Composition:

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

Units in package:

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

Class:

General sale

Prescription type:

General sale

Manufactured by:

Granules India Limited

Therapeutic indications:

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

Product summary:

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

Authorization date:

2008-07-25

Summary of Product characteristics

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