Coldrex PE Phenylephrine Cold & Flu Night & Day

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Chlorphenamine maleate 2mg; Dextromethorphan hydrobromide monohydrate 15mg equivalent to 10.95 mg dextromethorphan; Paracetamol 500mg;  ; Phenylephrine hydrochloride 5mg equivalent to 4.1 mg phenylephrine;  ;  ; Dextromethorphan hydrobromide monohydrate 15mg equivalent to 10.95 mg dextromethorphan; Paracetamol 500mg; Phenylephrine hydrochloride 5mg equivalent to 4.1 mg phenylephrine

Available from:

Haleon New Zealand ULC

INN (International Name):

Chlorphenamine maleate 2 mg

Pharmaceutical form:

Tablet

Composition:

Active: Chlorphenamine maleate 2mg Dextromethorphan hydrobromide monohydrate 15mg equivalent to 10.95 mg dextromethorphan Paracetamol 500mg   Phenylephrine hydrochloride 5mg equivalent to 4.1 mg phenylephrine     Excipient: Maize starch Microcrystalline cellulose Potassium sorbate Povidone Pregelatinised maize starch Purified talc Sodium laurilsulfate Stearic acid Active: Dextromethorphan hydrobromide monohydrate 15mg equivalent to 10.95 mg dextromethorphan Paracetamol 500mg Phenylephrine hydrochloride 5mg equivalent to 4.1 mg phenylephrine Excipient: Indigo carmine Maize starch Microcrystalline cellulose Potassium sorbate Povidone Pregelatinised maize starch Purified talc Sodium laurilsulfate Stearic acid

Units in package:

Blister pack, Aclra: PVC and Al Foil; Triplex: PVC/PE/PVdC and Al Foil; 24 (8 night + 16 day), 24 tablets

Class:

Pharmacy only

Prescription type:

Restricted

Manufactured by:

Kongo Chemical Co., Ltd

Product summary:

Package - Contents - Shelf Life: Blister pack, Aclra: PVC and Al Foil; Triplex: PVC/PE/PVdC and Al Foil; 24 (8 night + 16 day) - 24 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Aclra: PVC and Al Foil; Triplex: PVC/PE/PVdC and Al Foil; 48 (16night + 32 day) - 48 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2008-07-25

Patient Information leaflet

COLDREX
® PE
PHENYLEPHRINE COLD &
FLU NIGHT & DAY CAPLETS
_Day caplet - Paracetamol 500 mg, Dextromethorphan Hydrobromide 15 mg,
Phenylephrine _
_Hydrochloride 5 mg; _
_Night caplet - Paracetamol 500 mg, Dextromethorphan Hydrobromide 15
mg, Phenylephrine _
_Hydrochloride 5 mg and Chlorpheniramine Maleate 2 mg _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COLDREX PE
PHENYLEPHRINE COLD & FLU
NIGHT & DAY caplets.
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 PE PHENYLEPHRINE
COLD & FLU NIGHT & DAY
caplets 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 PE
PHENYLEPHRINE
COLD & FLU NIGHT &
DAY ARE USED FOR
COLDREX PE PHENYLEPHRINE
COLD & FLU NIGHT & DAY
CAPLETS are used for the
temporary relief of the following
symptoms of cold and flu: headache,
runny or blocked nose, sore throat,
dry cough, body aches and pains.
Reduces fever. The NIGHT caplet
also relieves runny nose, sneezing,
itchy and watery eyes and allows rest
by providing effective temporary
relief from these symptoms.
COLDREX PE PHENYLEPHRINE
COLD & FLU DAY caplets contain
the active ingredients paracetamol,
dextromethorphan hydrobromide and
phenylephrine hydrochloride.
COLDREX PE PHENYLEPHRINE
COLD & FLU NIGHT caplets
contain the active ingredients
paracetamol, dextromethorphan
hydrobromide, phenylephrine
hydrochloride and chlorpheniramine
maleate.
Paracetamol works to stop the pain
messages from getting through to the
brain. It also acts in the brain to
reduce fever.
Dextromethorphan hydrobromide is a
cough suppressant that is used to
suppress a dry cough.
Phenylephrine HCl works to reduce
nasal stuffiness.
Chlorpheniramine maleate belongs to
a group

Summary of Product characteristics

COLDREX
®
PE COLD &FLU DAY & NIGHT CAPLETS – DATA SHEET Page 1 of 16
COLDREX
® PE PHENYLEPHRINE COLD &FLU NIGHT & DAY
CAPLETS
DATA SHEET
Proprietary (Trade) Name: COLDREX PE Phenylephrine Cold & Flu Night &
Day
Active ingredients:
DAY caplet
Paracetamol (BP) 500 mg/caplet
Dextromethorphan hydrobromide (BP) 15 mg/caplet
Phenylephrine hydrochloride (BP) 5 mg/caplet
NIGHT caplet
Paracetamol (BP) 500 mg/caplet
Dextromethorphan hydrobromide (BP) 15 mg/caplet
Phenylephrine hydrochloride (BP) 5 mg/caplet
Chlorpheniramine maleate (BP) 2 mg/caplet
PRESENTATION
DAY caplet
Blue capsule-shaped tablets (caplets) with flat edges, one face is
embossed with a sun
graphic within an oval.
NIGHT caplet
White capsule-shaped tablets (caplets) with flat edges, one face is
embossed with a
crescent within an oval.
INDICATIONS
For the temporary relief of the following symptoms of colds and flu:
headache, runny or
blocked nose, sore throat, dry cough, body aches and pains. Reduces
fever.
DOSAGE AND ADMINISTRATION
_DAY Caplets (Blue): _
2 caplets in the morning and in the afternoon taken every 4-6
hours as necessary.
Maximum 4 DAY caplets in 24 hours.
_NIGHT Caplets (White):_
2 caplets at bedtime with water.
Maximum 2 NIGHT caplets in 24 hours.
COLDREX
®
PE COLD &FLU DAY & NIGHT CAPLETS – DATA SHEET Page 2 of 16
The NIGHT caplets may cause drowsiness.
Do not use the DAY caplets within 6 hours of the NIGHT caplets.
This product may cause sleeplessness if taken several hours before
going to bed.
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 aged 12 – 17
except on medical
advice.
Do not give to children under 12 years of age.
Do not exceed the stated dose or frequency of dose.
The lowest dose necessary to achieve efficacy should be used.
Should not be used with other medicines containing paracetamol,
dextromethorphan,
phenylephrine, chlorpheniramine, decongestants or antihistamines,
including cough and
cold medicines.
RENAL AND HEPATIC IMPAIRME