Dimetapp Multi Symptom Cough Cold & Flu

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dextromethorphan hydrobromide monohydrate 10mg;  ; Paracetamol 300mg; Phenylephrine hydrochloride 5mg

Available from:

Haleon New Zealand ULC

INN (International Name):

Dextromethorphan hydrobromide monohydrate 10 mg

Pharmaceutical form:

Liquid filled capsule

Composition:

Active: Dextromethorphan hydrobromide monohydrate 10mg   Paracetamol 300mg Phenylephrine hydrochloride 5mg Excipient: Gelatin Macrogol 400 Opacode white NSP-78-18022 Plasticizer A-810 Povidone Propylene glycol Purified water Sodium metabisulfite Sunset yellow FCF

Units in package:

Blister pack, 24 capsules

Class:

General sale

Prescription type:

Restricted

Manufactured by:

Divi's Laboratories Limited

Therapeutic indications:

Temporary relief from the symptoms of the common cold and flu.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 24 capsules - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2011-05-26

Summary of Product characteristics

NEW ZEALAND DATA SHEET
DIMETAPP MULTI SYMPTOM COUGH COLD & FLU
___________________________________________________________________________
Page 1 of 9
1 PRODUCT NAME
Dimetapp Multi Symptom Cough Cold & Flu Liquid Filled Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each liquid filled capsule contains:
Paracetamol 300 mg, Dextromethorphan hydrobromide monohydrate 10 mg,
Phenylephrine
hydrochloride 5 mg
Excipient(s) with known effect:
•
Sorbitol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Liquid Filled Capsule
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
For temporary relief from the symptoms of the common cold and flu such
as nasal
congestion, headaches, muscular aches, fever, body aches and pains,
sore throat, stuffy,
runny noses and dry irritating coughs.
4.2
Dose and method of administration
Adults and children 12 years and over:
Two (2) capsules should be taken orally with water, every 4-6 hours as
necessary.
Allow 4 - 6 hours between each dose.
Do not exceed 8 liquid capsules in 24 hours.
Adults should not take this product for more than a few days at a time
except on medical
advice.
Children and adolescents 12 years and over should not use this product
for more than 48
hours, except on medical advice.
Do not use in children under 12 years.
NEW ZEALAND DATA SHEET
DIMETAPP MULTI SYMPTOM COUGH COLD & FLU
___________________________________________________________________________
Page 2 of 9
4.3
Contraindications
Dimetapp Multi Symptom Cough Cold & Flu Liquid Caps are
contraindicated for use in
patients:
•
with known hypersensitivity to the active ingredients paracetamol,
phenylephrine
hydrochloride, or dextromethorphan hydrobromide monohydrate or
substances of
similar chemical structure or any other ingredient in the product
•
taking prescription medication for depression, psychiatric or
emotional conditions e.g.
a monoamine oxidase inhibitor (MAOI), selective serotonin reuptake
inhibitor (SSRI)
or for Parkinson’s disease, or for 2 weeks after stopping the
medicat