Duro-Tuss Cough Liquid Expectorant

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Bromhexine hydrochloride 0.8 mg/mL; Pholcodine 1 mg/mL;  ;  ;  

Disponible des:

iNova Pharmaceuticals (New Zealand) Limited

Designació comuna internacional (DCI):

Bromhexine hydrochloride 0.8 mg/mL

Dosis:

0.8mg/1mg per mL

formulario farmacéutico:

Oral solution

Composición:

Active: Bromhexine hydrochloride 0.8 mg/mL Pholcodine 1 mg/mL       Excipient: Citric acid Glycerol Grenadine flavour 053040 Hyetellose Methyl hydroxybenzoate Patent blue V Propyl hydroxybenzoate Purified water Quinoline yellow Saccharin sodium Sorbitol

Unidades en paquete:

Bottle, plastic, PET, sample, with pp CRC tamper evident wadded cap, 30 mL

clase:

Pharmacy only

tipo de receta:

Restricted

Fabricat per:

FDC Limited

Resumen del producto:

Package - Contents - Shelf Life: Bottle, plastic, PET, sample, with pp CRC tamper evident wadded cap - 30 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, PET, with pp CRC tamper evident wadded cap - 100 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, PET, with pp CRC tamper evident wadded cap - 200 mL - 24 months from date of manufacture stored at or below 30°C

Data d'autorització:

1998-05-06

Informació per a l'usuari

Duro-Tuss Cough Liquid Expectorant_January 2011 final.doc 
Page 1 of 3 pages 

DURO-TUSS
 TM
 COUGH LIQUID EXPECTORANT 

_BROMHEXINE HYDROCHLORIDE AND PHOLCODINE _

CONSUMER 
MEDICINE 
INFORMATION 
     _ _
WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about these medicines. 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 these medicines 
against the benefits they expect it will 
have for you. 

IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR DOCTOR 
OR PHARMACIST. 

KEEP THIS LEAFLET.  
You may need to read it again. 
WHAT DURO-TUSS COUGH 
LIQUID EXPECTORANT IS 
USED FOR 

Bromhexine helps to clear chest 
congestion by thinning the mucus in 
your air passages. 

Pholcodine is used to relieve dry 
coughs. 

Pholcodine works on the cough centre 
in the brain to control and help stop 
coughing.  

ASK YOUR PHARMACIST OR DOCTOR IF 
YOU HAVE ANY QUESTIONS ABOUT THIS 
MEDICINE. 
Your pharmacist or doctor may have 
given it for another reason. 

BEFORE YOU TAKE DURO-
TUSS COUGH LIQUID 
EXPECTORANT 

_WHEN YOU MUST NOT TAKE IT _

Do not use in children under 6 years of 
age. 

DO NOT TAKE THIS MEDICINE IF YOU HAVE 
AN ALLERGY TO: 
•  any medicine containing 
Bromhexine hydrochloride or 
Pholcodine  
•  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 o

Fitxa tècnica

NEW ZEALAND DATA SHEET
Page 1 of 6
1 PRODUCT NAME
Duro-Tuss Cough Liquid Expectorant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 mL of the medicine contains: pholcodine 15 mg and bromhexine
hydrochloride 12 mg.
Excipients with known effect:
Methyl hydroxybenzoate, propyl hydroxybenzoate, saccharin sodium and
sorbitol.
For full list of excipients, see section 6.1
.
3 PHARMACEUTICAL FORM
Oral solution.
Clear green, slightly viscous liquid with an odour of grenadine.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Clearing chest congestion and relieving coughs.
4.2
Dose and method of administration
For oral administration.
AGE
DOSAGE
HOW OFTEN
Adults & children 12 years & over
10 – 15 mL
Every 6 hours as required
(Maximum 4 times a day)
Children 6 – 11 years
5 – 10 mL
Children under 6 years
Do not use
4.3
Contraindications
•
Children under the age of 6 years.
•
Hypersensitivity to pholcodine, bromhexine hydrochloride or any of the
excipients listed in
section 6.1.
•
Patients in, or at risk of, developing respiratory failure or during
acute asthma attacks, as it
may depress respiration.
•
Patients with chronic bronchitis, COPD, bronchiolitis or
bronchiectasis due to sputum
retention.
•
Patients with renal or hepatic failure.
•
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days
of stopping such
treatment (see also section 4.5
).
4.4
Special warnings and precautions for use
Use with caution in patients with liver or renal disease.
Duro-Tuss Cough Liquid Expectorant should be used with caution in
patients with chronic or
persistent cough, asthma, including an acute asthma attack, or where
cough is accompanied by
excessive secretions.
Use with caution in patients with gastric ulceration.
NEW ZEALAND DATA SHEET
Page 2 of 6
Concomitant use of Duro-Tuss Cough Liquid Expectorant with other
medicines intended to treat the
symptoms of the common cold is not recommended.
Patients should be advised to expect an increase in the flow of mucus
secretions.
Severe cutaneous adverse reac