Coldrex Hot Remedy Cold & Flu Plus with Decongestant

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Paracetamol 1000mg;  ;  ;  ; Phenylephrine hydrochloride 10mg equivalent to 8.2 mg phenylephrine;  

Available from:

Haleon New Zealand ULC

INN (International Name):

Paracetamol 1000 mg

Pharmaceutical form:

Powder for oral solution

Composition:

Active: Paracetamol 1000mg       Phenylephrine hydrochloride 10mg equivalent to 8.2 mg phenylephrine   Excipient: Ascorbic acid Citric acid Colloidal silicon dioxide Lemon flavour 610399E Maize starch Saccharin sodium Sodium citrate dihydrate Sodium cyclamate Sucrose Turmeric yellow

Units in package:

Sachet, laminate, paper/PE/Al foil/PE; 10 sachets, 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 blocked nose, runny nose, headaches, body aches and pain, sore throat. Reduces fever.

Product summary:

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

Authorization date:

2008-07-25

Patient Information leaflet

COLDREX
®
HOT REMEDY COLD & FLU PLUS WITH DECONGESTANT HOT LEMON
1
COLDREX
® HOT
REMEDY COLD & FLU
PLUS WITH DECONGESTANT
HOT LEMON
_Paracetamol 1000 mg and Phenylephrine Hydrochloride 10 mg _
CONSUMER MEDICINE INFORMATION
Please read this information before you start using this medicine.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COLDREX HOT
REMEDY COLD & FLU PLUS
WITH DECONGESTANT HOT
LEMON.
It does not contain all the available
information.
It does not take the place of talking to
your pharmacist or doctor.
All medicines have risks and
benefits. Your pharmacist or doctor
has weighed the risks of you taking
COLDREX HOT REMEDY COLD
& FLU PLUS WITH
DECONGESTANT HOT LEMON
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT COLDREX HOT
REMEDY COLD & FLU
PLUS WITH
DECONGESTANT HOT
LEMON IS USED FOR
COLDREX HOT REMEDY COLD
& FLU PLUS WITH
DECONGESTANT HOT LEMON is
used for the fast, effective temporary
relief from cold & flu symptoms such
as blocked nose, runny nose,
headaches, body aches and pain, sore
throat. Reduces fever.
COLDREX HOT REMEDY COLD
& FLU PLUS WITH
DECONGESTANT HOT LEMON
contain the active ingredients
paracetamol and Phenylephrine
hydrochloride
Paracetamol works to stop the pain
messages from getting through to the
brain. It also acts in the brain to
reduce fever.
Phenylephrine hydrochloride belongs
to a group of medicines called
sympathomimetic decongestants.
It works by reducing congestion in
the upper respiratory tract, including
the nose, nasal passages and sinuses,
and making it easier to breathe.
ASK YOUR PHARMACIST OR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT THIS
MEDICINE.
Your pharmacist or doctor may have
given it for another reason.
This medicine is not addictive.
It is only available from your
pharmacist.
BEFORE YOU TAKE/GIVE
COLDREX HOT
REMEDY COLD & FLU
PLUS WITH
DECONGESTANT HOT
LEMON
_WHEN YOU MUST

Summary of Product characteristics

NEW ZEALAND DATASHEET 
COLDREX HOT REMEDY COLD & FLU PLUS WITH 
DECONGESTANT POWDER FOR ORAL SOLUTION HOT 
LEMON 
PANADOL COLD & FLU MAX + DECONGESTANT 
POWDER FOR ORAL SOLUTION  
Paracetamol (BP) 1000mg and Phenylephrine
Hydrochloride (BP) 10mg 
PRESENTATION 
Pale yellow, free-flowing heterogenous powder with
an odour of lemon. 
INDICATIONS 
Fast, effective
temporary relief from cold & flu symptoms such as blocked 
nose, runny nose, headaches, body aches and pain, sore
throat.  Reduces 
fever. 
DOSAGE AND ADMINISTRATION 
ADULTS AND CHILDREN AGED 12 YEARS AND OVER 
One powder sachet every four to six hours as necessary.   
Maximum of 4 powder sachets within 24 hours. 
Do not use for more than a few days at a time in
adults without medical 
advice. 
Should not be used for more than 48 hours in children aged 12
to 17 except 
on medical advice. 
Do not use in children under 12 years of age. 
Do not exceed the stated dose. 
Should not be used with other paracetamol-containing products, 
decongestants or cough and cold medicines. 
Do not use within several hours of going to bed
as it may cause 
sleeplessness. 
Minimum dosing interval:  4 hours 
RENAL AND HEPATIC IMPAIRMENT 
Patients who have been diagnosed with
liver or kidney impairment must seek 
medical advice before taking this medication.  The
restrictions related to the 
use of such combinations in these patients is primarily a
consequence of the 
paracetamol content of the product.  (See WARNINGS AND 
PRECAUTIONS.) 
CONTRAINDICATIONS 
Contraindicated in patients with
a previous history of hypersensitivity to 
paracetamol, phenylephrine hydrochloride or any of the
excipients. 
This medicine is also contraindicated in patients who are
taking, or have 
taken within the last two weeks, monoamine oxidase inhibitors. 
(See 
INTERACTIONS.) 
WARNINGS AND PRECAUTIO