Dimetapp Cough & Cold Colour Free

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Brompheniramine maleate 0.4 mg/mL;  ; Dextromethorphan hydrobromide monohydrate 2 mg/mL;  ;  ; Phenylephrine hydrochloride 1 mg/mL;  

Доступно од:

Haleon New Zealand ULC

INN (Међународно име):

Brompheniramine maleate 0.4 mg/mL

Фармацеутски облик:

Elixir

Састав:

Active: Brompheniramine maleate 0.4 mg/mL   Dextromethorphan hydrobromide monohydrate 2 mg/mL     Phenylephrine hydrochloride 1 mg/mL   Excipient: Citric acid Ethanol Glycerol Grape flavour 11540 Grape flavour 5-8994 Propylene glycol Purified water Saccharin sodium Sodium benzoate Sorbitol

Јединице у пакету:

Bottle, glass, Amber, 25 mL

Класа:

Pharmacy only

Тип рецептора:

Restricted

Произведен од:

Keshava Organics Pvt Ltd

Терапеутске индикације:

Temporarily suppresses dry coughs and relieves common cold symptoms like nasal congestion, runny nose, sneezing and itchy, watery eyes.

Резиме производа:

Package - Contents - Shelf Life: Bottle, glass, Amber - 25 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, Amber, Sample pack - 45 mL - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, Amber - 50 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

Датум одобрења:

2002-04-18

Карактеристике производа

NEW ZEALAND DATA SHEET
DIMETAPP COUGH & COLD COLOUR FREE
___________________________________________________________________________
Page 1 of 9
1 PRODUCT NAME
Dimetapp Cough & Cold Colour Free Elixir
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of oral liquid contains:
Brompheniramine maleate 2 mg, Phenylephrine hydrochloride 5 mg,
Dextromethorphan
hydrobromide monohydrate 10 mg.
Excipient(s) with known effect:
•
Sodium benzoate
•
Sorbitol
•
Ethanol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Elixir
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Dimetapp Cough & Cold Colour Free temporarily suppresses dry coughs
and relieves
common cold symptoms like nasal congestion, runny nose, sneezing and
itchy, watery eyes.
4.2
Dose and method of administration
Children 6 to under 12 years:
5 mL Every 4 hours, as necessary
Adults and children 12 years and over:
10 mL Every 4 hours, as necessary
Do not exceed 6 doses in any 24 hour period.
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
Dimetapp Cough & Cold Colour Free is contraindicated for use in
patients:
•
With known hypersensitivity to the active ingredients, brompheniramine
maleate,
phenylephrine hydrochloride and Dextromethorphan hydrobromide
monohydrate or
NEW ZEALAND DATA SHEET
DIMETAPP COUGH & COLD COLOUR FREE
___________________________________________________________________________
Page 2 of 9
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 Parkinson’s disease, or for 2 weeks after stopping the
medication. If you are unsure
if your prescription medication contains any of these drugs, ask a
doctor or
pharmacist before taking this product.
•
with severe hypertension or coronary artery disease
•
with narrow-angle glaucoma
•
wit