Robitussin Cough & Chest Congestion

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Kupi sada

Preuzimanje Uputa o lijeku (PIL)
18-01-2021
Preuzimanje Svojstava lijeka (SPC)
27-06-2020

Aktivni sastojci:

Dextromethorphan hydrobromide monohydrate 3 mg/mL;  ;  ; Guaifenesin 20 mg/mL;  ; Dextromethorphan hydrobromide monohydrate 3 mg/mL; Guaifenesin 20 mg/mL; Dextromethorphan hydrobromide monohydrate 3 mg/mL; Guaifenesin 20 mg/mL

Dostupno od:

Haleon New Zealand ULC

INN (International ime):

Dextromethorphan hydrobromide monohydrate 3 mg/mL

Farmaceutski oblik:

Oral solution

Sastav:

Active: Dextromethorphan hydrobromide monohydrate 3 mg/mL     Guaifenesin 20 mg/mL   Excipient: Allura red AC Cherry flavour (vanilla) 21146 Cherry flavour 119062 Citric acid Ethanol Lemon wonf S-2522 Glycerol Menthol Propylene glycol Purified water Saccharin sodium Sodium benzoate Sorbitol Sweet flavour 13540488 Vanilla flavour 52089A Active: Dextromethorphan hydrobromide monohydrate 3 mg/mL Guaifenesin 20 mg/mL Excipient: Allura red AC Cherry flavour (vanilla) 21146 Cherry flavour 119062 Citric acid Ethanol Glycerol Lemon Flavour 462924 Menthol Propylene glycol Purified water Saccharin sodium Sodium benzoate Sorbitol Sweet flavour 13540488 Vanilla flavour 52089A Active: Dextromethorphan hydrobromide monohydrate 3 mg/mL Guaifenesin 20 mg/mL Excipient: Allura red AC Cherry flavour (vanilla) 21146 Cherry flavour 119062 Citric acid Ethanol Glycerol Lemon Flavour 462924 Menthol Propylene glycol Purified water Saccharin sodium Sodium benzoate Sorbitol Sweet flavour SC822921 Vanilla flavour 52089A

Jedinice u paketu:

Bottle, glass, amber, sample, 25 mL

Razred:

Pharmacy only

Tip recepta:

Restricted

Proizveden od:

F Hoffmann-La Roche Ltd

Terapijske indikacije:

For the temporary relief of cough and chest congestion due to cold and flu.

Proizvod sažetak:

Package - Contents - Shelf Life: Bottle, glass, amber, sample - 25 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, amber, sample - 45 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, amber - 100 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, amber - 200 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, amber - 250 mL - 60 months from date of manufacture stored at or below 25°C

Datum autorizacije:

1994-10-12

Uputa o lijeku

                                CMI_ROBITUSSIN COUGH & CHEST CONGESTION ORAL SOLUTION_1 MAR 2011
1
ROBITUSSIN COUGH
& CHEST CONGESTION ORAL LIQUID
____________________________________________________________________________
CONSUMER MEDICINE INFORMATION (FOR NEW ZEALAND)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Robitussin Cough &
Congestion. 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 Robitussin
Cough & Chest Congestion 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 ROBITUSSIN COUGH
& CHEST CONGESTION IS
USED FOR

Expectorant, cough suppressant_. _

For the temporary relief of cough
and chest congestion due to cold
and flu.
Robitussin Cough & Chest Congestion
combines the action of the expectorant
guaiphenesin and the cough
suppressant dextromethorphan
Guaiphenesin is an expectorant that
loosens and reduces the thickness of
phlegm, making it easier to cough up
Dextromethorphan is a cough
suppressant that acts on the cough
centre in the brain to suppress a dry
cough.
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/GIVE
ROBITUSSIN COUGH &
CHEST CONGESTION
_WHEN YOU MUST NOT TAKE IT _
DO NOT GIVE THIS MEDICINE TO:

children under 6 years of age
DO NOT TAKE ROBITUSSIN COUGH &
CHEST CONGESTION IF YOU HAVE AN
ALLERGY TO:

any medicine containing
guaiphenesin or dextromethorphan

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 
                                
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Svojstava lijeka

                                NEW ZEALAND DATA SHEET
ROBITUSSIN COUGH AND CHEST CONGESTION
___________________________________________________________________________
Page 1 of 7
1 PRODUCT NAME
Robitussin Cough & Chest Congestion Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of oral solution contains:
Guaifenesin 20 mg, Dextromethorphan hydrobromide monohydrate 3 mg
Excipient(s) with known effect:
•
Sodium benzoate
•
Sorbitol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Robitussin Cough & Chest Congestion is an expectorant cough
suppressant. For the
temporary relief of cough and chest congestion due to cold and flu
4.2
Dose and method of administration
Every 6 to 8 hours orally when necessary:
Adults and Children 12 years and over:
10 mL
Children 6 years – under 12 years:
5 mL
Do not exceed 4 doses in 24 hours. Do not use in children under 6
years of age. Use in
children aged 6 to 11 years only on the advice of a doctor, pharmacist
or nurse practitioner.
4.3
Contraindications
Robitussin Cough & Chest Congestion is contraindicated for use in:
•
patients with known hypersensitivity or idiosyncratic reaction to
Guaifenesin,
Dextromethorphan hydrobromide monohydrate or any of the other
ingredients in the
product.
•
patients taking a prescription monoamine oxidase inhibitor (MAOI), a
selective
serotonin reuptake inhibitor (SSRI), or other medications for
depression, psychiatric,
or emotional conditions, or Parkinson's disease, or for 2 weeks after
stopping the
medication. If you are not sure if your prescription medication
contains one of these
drugs, ask a doctor or pharmacist before taking this product.
NEW ZEALAND DATA SHEET
ROBITUSSIN COUGH AND CHEST CONGESTION
___________________________________________________________________________
Page 2 of 7
•
patients having an acute asthma attack
•
patients with impaired hepatic function
•
patients with respiratory insufficiency and respiratory depression
•
children under 6
                                
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