CHEMISTS' OWN COUGH, COLD & FLU DAY/NIGHT tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

paracetamol, Quantity: 500 mg; pseudoephedrine hydrochloride, Quantity: 30 mg; chlorphenamine maleate, Quantity: 2 mg

から入手可能:

Aspen Pharma Pty Ltd

INN（国際名）:

chlorphenamine maleate,dextromethorphan hydrobromide monohydrate,Paracetamol,Pseudoephedrine hydrochloride

医薬品形態:

Tablet, film coated

構図:

Excipient Ingredients: hydrogenated vegetable oil; croscarmellose sodium; pregelatinised maize starch; Carnauba Wax; magnesium stearate; microcrystalline cellulose; povidone; titanium dioxide; indigo carmine; hyprolose; iron oxide red; iron oxide black

投与経路:

Oral

パッケージ内のユニット:

6 night tablets, 18 day tablets

処方タイプ:

(S3) Pharmacist Only Medicine

適応症:

Provides fast and effective relief from the symptoms of cold and flu. The non-drowsy Day tablet temporarily relieves: blocked noses, runny noses, nagging cough, headaches, body aches and pains, and fever. The Night tablet contains an antihistamine and temporarily relieves: blocked noses, headaches, body aches and pains, and fever.

製品概要:

Visual Identification: Pale blue film coated round plain tablet with a break bar; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Licence status A

承認日:

2017-08-30

情報リーフレット

Chemists’ Own Cough, Cold & Flu Day /Night Tablets - CMI
Page 1 of 4
CHEMISTS’ OWN COUGH, COLD & FLU DAY/NIGHT
TABLETS
_Pseudoephedrine hydrochloride _
_Paracetamol _
_Dextromethorphan hydrobromide monohydrate _
_Chlorphenamine maleate _
____________________________________________________________________________________________
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Chemists’ Own Cough, Cold & Flu
Day /Night Tablets.
It
does
not
contain
all
of
the
available
information
about
Chemists’ Own Cough, Cold & Flu
Day/Night Tablets.
It does not replace talking to your
doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
or
pharmacist has weighed the risks
of
you
taking
Chemists’
Own
Cough,
Cold
&
Flu
Day/Night
Tablets against the benefits he or
she expects it will have.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
ARE
CHEMISTS’
OWN
COUGH,
COLD
&
FLU DAY/NIGHT TABLETS
The
name
of
your
medicine
is
Chemists’ Own Cough, Cold & Flu
Day/Night Tablets.
The active ingredients in the day
tablet
are
pseudoephedrine
hydrochloride,
paracetamol
and
dextromethorphan
hydrobromide
monohydrate.
_ _
The active ingredients in the night
tablet
are
pseudoephedrine
hydrochloride,
paracetamol
and
chlorphenamine maleate.
Chemists’ Own Cough, Cold & Flu
Day/Night
Tablets_ _
belong
to
a
group
of
medicines
for
the
treatment of symptoms of colds
and flu.
Pseudoephedrine
hydrochloride_ _
relieves
blocked
nose
and
sinuses.
Paracetamol
relieves
pain
and
reduces
fever.
Dextromethorphan
hydrobromide
monohydrate
suppresses
coughing.
Chlorphenamine
maleate
relieves
symptoms
of
allergies including blocked nose
and sinuses.
WHAT CHEMISTS’ OWN
COUGH,
COLD
&
FLU
DAY/NIGHT TABLETS ARE
USED FOR
Chemists’ Own Cough, Cold & Flu
Day/Night
tablets_ _
belong
to
a
group
of
medicines
for
the
treatment of symptoms of colds
and flu.
Your
doctor
or
pha

製品の特徴

1
AUSTRALIAN PRODUCT INFORMATION – CHEMISTS’ OWN COUGH,
COLD & FLU DAY/NIGHT (PSEUDOEPHEDRINE HYDROCHLORIDE +
PARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE
MONOHYDRATE & CHLORPHENAMINE MALEATE +
PSEUDOEPHEDRINE HYDROCHLORIDE + PARACETAMOL) TABLETS
1
NAME OF THE MEDICINE
Day Tablets: pseudoephedrine hydrochloride + paracetamol +
dextromethorphan hydrobromide
monohydrate
Night Tablets: chlorphenamine maleate + pseudoephedrine hydrochloride
+ paracetamol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each day tablet contains the active ingredients: Paracetamol 500 mg,
Pseudoephedrine hydrochloride
30 mg and Dextromethorphan hydrobromide monohydrate 15 mg.
Each night-time tablet contains the active ingredients: Paracetamol
500 mg, Pseudoephedrine
hydrochloride 30 mg and Chlorphenamine maleate 2 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Day tablet: Pale yellow film coated round plain tablet with a break
bar on one side.
Night tablet: Pale blue film coated round plain tablet with a break
bar on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Provides fast and effective relief from the symptoms of cold and flu.
The non-drowsy “DAY” tablet temporarily relieves blocked noses,
runny noses, nagging cough,
headaches, body aches, pains, and fever.
The “NIGHT” tablet contains an antihistamine and temporarily
relieves blocked noses, headaches,
body aches, pains, and fever.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 12 YEARS AND OVER:
Daytime:
One to two pale yellow ‘DAY’ tablets in the morning, at midday and
again in the
afternoon.
Night-time:
Take one to two pale blue ‘NIGHT’ tablets at bedtime.
Maximum of 8 tablets in 24 hours.
Duration of use: Chemists’ Own Cough, Cold & Flu Day/Night Tablets
should not be taken for more
than 48 hours except on medical advice.
4.3
C
ONTRAINDICATIONS
Chemists’ Own Cough, Cold & Flu Day & Night Tablets are
contraindicated in patients:
•
With
known
sensitivity
to
paracetamol,
pseudoephedrin