Mucinex

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Guaifenesin 600mg; Guaifenesin 600mg; Guaifenesin 600mg

Available from:

Reckitt Benckiser (New Zealand) Limited

INN (International Name):

Guaifenesin 600 mg

Dosage:

600 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Guaifenesin 600mg Excipient: Carbomer 934P FD & C Blue I aluminium lake dye Hypromellose Magnesium stearate Microcrystalline cellulose Sodium starch glycolate Active: Guaifenesin 600mg Excipient: Carbomer 934P FD & C Blue I aluminium lake dye Hypromellose Magnesium stearate Microcrystalline cellulose Sodium starch glycolate Active: Guaifenesin 600mg Excipient: Carbomer 934P FD & C Blue I aluminium lake dye Hypromellose Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

Units in package:

Blister pack, PVdC (Nottingham site only), 41 tablets

Class:

Restricted

Prescription type:

Restricted

Manufactured by:

Delta Synthetic Co Ltd

Therapeutic indications:

· Helps loosen phlegm and thin bronchial secretions. · Symptomatic relief of deep chesty coughs. · Expectorant for productive cough.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVdC (Nottingham site only) - 41 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PCTFE/Foil/paper laminate - 41 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 41 tablets - 3 years from date of manufacture stored at or below 25°C - Bottle, HDPE - 60 tablets - 3 years from date of manufacture stored at or below 25°C - Bottle, HDPE - 100 tablets - 3 years from date of manufacture stored at or below 25°C

Authorization date:

2008-08-18

Summary of Product characteristics

Page 1 of 5
NEW ZEALAND DATA SHEET
MUCINEX AND MAXIMUM STRENGTH MUCINEX
1. PRODUCT NAME
Mucinex and Maximum Strength Mucinex
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MUCINEX: Each modified release tablet contains 600 mg guaifenesin.
MAXIMUM STRENGTH MUCINEX: each modified release tablet contains 1200
mg
guaifenesin.
For a full list of excipients see Section 6.1.
3. PHARMACEUTICAL FORM
MUCINEX: A blue and white bilayered, oval tablet imprinted with
‘600’ on the white
immediate release layer and ‘Mucinex’ on the blue sustained
release layer.
MAXIMUM STRENGTH MUCINEX: A blue and white bilayered, oval tablet
imprinted with
‘1200’ on the white immediate release layer and ‘Mucinex’ on
the blue sustained
release layer.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Helps loosen phlegm and thin bronchial secretions.
Symptomatic relief of deep chesty cough
Expectorant for productive cough.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
_ADULTS AND CHILDREN OVER 12 YEARS _
MUCINEX 600 MG TABLETS
One to two tablets to be taken with water every 12 hours.
Do not exceed FOUR tablets in 24 hours.
MAXIMUM STRENGTH MUCINEX 1200 MG TABLETS
One tablets to be taken with water every 12 hours.
Do not exceed TWO tablets in 24 hours.
Page 2 of 5
The tablet should not be chewed because this will affect the
modified-release
characteristics of the tablet.
CHILDREN UNDER 12 YEARS
Do not use.
ELDERLY
No dosage adjustment is considered necessary in the elderly.
_4.3 CONTRAINDICATIONS _
Hypersensitivity to guaifenesin or to any of the excipients in the
product.
_4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
If symptoms persist or no improvements are observed, do not exceed the
recommended dose.
Seek medical advice if suffering from chronic cough or asthma,
bronchitis,
emphysema, chronic obstructive pulmonary disease (COPD) or smoker’s
cough.
Use in caution in patients with renal impairment.
Not recommended for concomitant use with a cough suppressant.
Do not take if you are pregnant or breast feeding unless re