Strepsils Dry Cough

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dextromethorphan hydrobromide monohydrate 5mg;  ; Dextromethorphan hydrobromide monohydrate 5mg

Available from:

Reckitt Benckiser (New Zealand) Limited

INN (International Name):

Dextromethorphan hydrobromide monohydrate 5 mg

Dosage:

5 mg

Pharmaceutical form:

Lozenge

Composition:

Active: Dextromethorphan hydrobromide monohydrate 5mg   Excipient: Anise oil Capsicum tincture Cassia oil Clove oil Eucalyptus oil Glucose liquid Menthol Peppermint oil Ponceau 4R Saccharin sodium Sucrose Sunset yellow FCF Active: Dextromethorphan hydrobromide monohydrate 5mg Excipient: Anise oil Capsicum tincture Cassia oil Clove oil Eucalyptus oil Glucose liquid Menthol as levomethol Peppermint oil Ponceau 4R Saccharin sodium Sucrose Sunset yellow FCF

Units in package:

Blister pack, Clear PVC/PVDC/Al x 2, 2 lozenges

Class:

General sale

Prescription type:

Restricted

Manufactured by:

Wockhardt Ltd

Product summary:

Package - Contents - Shelf Life: Blister pack, Clear PVC/PVDC/Al - 2 lozenges - 36 months from date of manufacture stored at or below 30°C - Blister pack, Clear PVC/PVDC/Al - 6 lozenges - 36 months from date of manufacture stored at or below 30°C - Blister pack, Clear PVC/PVDC/Al - 8 lozenges - 36 months from date of manufacture stored at or below 30°C - Blister pack, Clear PVC/PVDC/Al - 12 lozenges - 36 months from date of manufacture stored at or below 30°C - Blister pack, Clear PVC/PVDC/Al - 16 lozenges - 36 months from date of manufacture stored at or below 30°C - Blister pack, Clear PVC/PVDC/Al - 32 lozenges - 36 months from date of manufacture stored at or below 30°C - Blister pack, Clear PVC/PVDC/Al - 36 lozenges - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1969-12-31

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet Template v 1.1 March 2017
Page 1 of 7
STREPSILS DRY COUGH 5MG DEXTROMETHORPHAN HYDROBROMIDE
1 PRODUCT NAME
Strepsils Dry Cough Lozenge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dextromethorphan hydrobromide monohydrate 5 mg
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Strepsils Dry Cough are light orange coloured circular lozenges with
each lozenge containing
5mg Dextromethorphan hydrobromide monohydrate
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Strepsils Dry Cough helps to soothe sore throats.
4.2
DOSE AND METHOD OF ADMINISTRATION
POSOLOGY: If symptoms are severe or persist for more than 7 days seek
advice of doctor (see
section 4.4).
ADULTS, THE ELDERLY AND CHILDREN 12 YEARS OF AGE AND OVER: Take 2
lozenges (one immediately
after the other) and allow each lozenge to dissolve slowly in the
mouth; may be repeated
every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as
directed by a doctor.
CHILDREN UNDER 12 YEARS OF AGE: The product is contraindicated in
children under 12 years of
age.
METHOD OF ADMINISTRATION: For oral administration
4.3
CONTRAINDICATIONS
Hypersensitivity to dextromethorphan hydrobromide or to any of the
excipients in the
product.
Dextromethorphan should not be given to patients with or at risk of
developing respiratory
failure, respiratory insufficiency and respiratory depression, e.g.
asthma, chronic obstructive
airways disease, or pneumonia.
Patients taking monoamine oxidase inhibitors (MAOIs) or who have taken
MAOIs with the
previous 14 days.
Children under 12 years of age.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet Template v 1.1 March 2017
Page 2 of 7
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms are severe or persist for more than 7 days, or are
accompanied by fever,
headache, nausea and vomiting, seek the advice of a doctor.
Cases of dextromethorphan abuse have been reported. Caution is
particularly
recommended for adolescents and young adults as well as in patients
with a history of