DURO-TUSS Expectorant Cough Liquid

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Bromhexine HCl; PHOLCODINE

Available from:

iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch

INN (International Name):

Bromhexine HCl; PHOLCODINE

Units in package:

90 ml

Manufactured by:

ENSIGN LABS PTY LTD

Patient Information leaflet

1
_Consumer Medication Information Leaflet (RiMUP) _
DURO-TUSS EXPECTORANT COUGH
LIQUID
Pholcodine 1mg/mL / Bromhexine Hydrochloride 0.8mg/mL
WHAT IS IN THIS LEAFLET
1.
What DURO-TUSS Expectorant
Cough Liquid is used for
2.
How DURO-TUSS Expectorant
Cough Liquid works
3.
Before you use DURO-TUSS
Expectorant Cough Liquid
4.
How to use DURO-TUSS
Expectorant Cough Liquid
5.
While you are using it
6.
Side effects
7.
Storage and disposal of DURO-
TUSS Expectorant Cough Liquid
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DURO-TUSS EXPECTORANT
COUGH LIQUID IS USED FOR
DURO-TUSS Expectorant Cough
Liquid is used to relieve excessive
cough associated with phlegm.
HOW DURO-TUSS EXPECTORANT
COUGH LIQUID WORKS
Pholcodine, which works on the cough
center in the brain to control and help
stop coughing.
Bromhexine helps to clear chest
congestion by thinning the mucus in
the air passage.
BEFORE YOU USE DURO-TUSS
EXPECTORANT COUGH LIQUID
_-When you must not use it _
Do not use this medicine if you have
an allergy to:
•
any medicine containing
Pholcodine or Bromhexine
hydrochloride
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
_ _
•
wheezing or difficulty breathing
_ _
•
swelling of the face, lips, tongue or
other parts of the body
_ _
•
rash, itching or hives on the skin.
Do not take this medicine if you have
•
Severe asthma, bronchitis or other
serious respiratory conditions.
Do not take this medicine after the
expiry date printed on the pack or if the
packaging is torn or shows signs of
tampering.
If you are not sure whether the patient
should start using this medicine, talk to
your pharmacist or doctor.
_-Before you start to use it _
Tell your pharmacist if you have
allergies to any other medicines, foods,
preservatives or dyes.
Tell your doctor or pharmacist if the
patient has or has had any of the
following medical conditions:
•
Liver problems
•
Kidney problems
•

Summary of Product characteristics

Black
ARTWORK
COLOUR
100%
JOB NO. :
JB-02146
UIC
:
A2916
SKU
:
100494
A2916_DURO-TUSS EXPECTORANT SOLN 90ML
COMPONENT : LEAFLET
COUNTRY : MY
DIELINE REF: PP-1026
EMO: ENSIGN
PRINTER: Xxxxxx Xxxxxxxxxxxx
PLEASE NOTE
V7
G247 FILE NAME:
89022_A2916_DURO-TUSS EXPECTORANT
SOLN 90ML_MY_LT_V7
09.10.19 - V0 - Artwork build - Sunny
24.10.19 - V1 - Amends - Chanon
05.11.19 - V2 - Update Dieline - Chanon
14.11.19 - V3 - Amend - Pornpawee
03.08.20 - V4 - Amend - Sunny
05.08.20 - V5 - Amend - Chanon
18.08.20 - V6 - Amend - Chanon
19.08.20 - V7 - Amend - Chanon
Guide
THIS HI RES PDF IS NOT TO BE USED AS FINAL ARTWORK
SUPPLIER INFORMATION MAY BE PRESENT ON THE
PACKAGING
EMO/PRINTING VENDOR:
PLEASE SHARE THE ARTWORK PDF TO PRINTER FOR
CHECKS ON:
• COLOURS - NO. OF COLOURS, SEQUENCE, CMYK/PMS
• TEXT - LINE THICKNESS, FONT SIZE
• DIELINE - SIZE, EYEMARK, PRINT DIRECTION
• CODING - SIZE, LOCATION, VFA, FORMAT BKG COLOUR
ANY ADDITONAL INFORMATION AND TECHNICAL CHECK
REQUIRED BY EMO ON THE ARTWORK BEFORE
APPROVING.
DURO-TUSS
®
Expectorant Cough Liquid
PRODUCT DESCRIPTION
A clear green, slightly viscous solution with an odour of grenadine.
COMPOSITION
Each 5mL contains
Pholcodine 5mg
4.713 mm
Font Size: 18 pt
Font Size: 6.5 pt
Font Size: 6.5 pt
2.748 mm
1.702 mm
1.688 mm
1.799 mm
A2916
Font Size: 7 pt
DURO-TUSS
®
Expectorant Cough Liquid
PRODUCT DESCRIPTION
A clear green, slightly viscous solution with an odour of grenadine.
COMPOSITION
Each 5mL contains
Pholcodine 5mg
Bromhexine Hydrochloride 4mg
Methyl Hydroxybenzoate 0.1%w/v and Propyl Hydroxybenzoate 0.02%w/v
as preservatives.
PHARMACODYNAMICS
Cough suppressant and mucolytic giving relief over 8 to 10 hours.
Pholcodine:
Pholcodine is an opioid chemically related to morphine. Pholcodine is
a cough
suppressant and has a mild sedative effect which relieves local
irritation of the
respiratory tract over 8 to 10 hours. Pholcodine acts primarily on the
CNS causing
depression of the cough reflex which is due partly to the direct
effect on the cough
centre in the medulla. Pholco