BENYLIN WET COUGH MENTHOL SYRUP

Kraj: Republika Południowej Afryki

Język: angielski

Źródło: South African Health Products Regulatory Authority (SAHPRA)

Dostępny od:

Johnson & Johnson (Pty) Ltd û East London

Dawkowanie:

See ingredients

Forma farmaceutyczna:

SYRUP

Skład:

EACH 10 ml SYRUP CONTAINS GUAIFENESIN 200 mg

Status autoryzacji:

Registered

Data autoryzacji:

1995-11-03

Ulotka dla pacjenta

Johnson & Johnson (Pty) Ltd
BENYLIN WET COUGH MENTHOL SYRUP
Each 10 mL contains:
200 mg guaifenesin
DATE OF APPROVAL: 19 JANUARY 2022
Page 1 of 8
BENYLIN WET COUGH MENTHOL
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S0
BENYLIN WET COUGH MENTHOL SYRUP
GUAIFENESIN
CONTAINS SUGAR: EACH 10 ML CONTAINS 2,0 G SUGAR AND 5,0 ML GLUCOSE.
CONTAINS SWEETENER: EACH 10 ML CONTAINS 30 MG SACCHARIN SODIUM.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Benylin Wet Cough Menthol is available without a doctor’s
prescription, for you to treat a mild
illness.
Nevertheless, you still need to use Benylin Wet Cough Menthol
carefully to get the best results
from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share Benylin Wet Cough Menthol with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see your doctor if your symptoms worsen or do not improve
after 7 days.
WHAT IS IN THIS LEAFLET
1.
What Benylin Wet Cough Menthol is and what it is used for.
2.
What you need to know before you use Benylin Wet Cough Menthol.
3.
How to use Benylin Wet Cough Menthol.
4.
Possible side effects.
5.
How to store Benylin Wet Cough Menthol.
6.
Contents of the pack and other information.
Johnson & Johnson (Pty) Ltd
BENYLIN WET COUGH MENTHOL SYRUP
Each 10 mL contains:
200 mg guaifenesin
DATE OF APPROVAL: 19 JANUARY 2022
Page 2 of 8
1.
WHAT BENYLIN WET COUGH MENTHOL IS AND WHAT IT IS USED FOR
Benylin Wet Cough Menthol contains guaifenesin (an expectorant) to
help loosen mucus
(phlegm) from the lungs and make it easier to cough up.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BENYLIN WET COUGH MENTHOL
DO NOT USE BENYLIN WET COUGH MENTHOL
•
If you are hypersensitive (allergic) to guaifenesin or any of the
other ingredients of Benylin
Wet Cough Menthol (see WHAT BENYLIN WET COUGH MENTHOL CONTAINS).
•
If you are pregnant or breastfeeding (see PREGNANCY, BREASTFEEDING AND
FERTILITY).
•
If you have acute porphyria.
WARNINGS AND PR

Charakterystyka produktu

Johnson & Johnson (Pty) Ltd
BENYLIN WET COUGH MENTHOL SYRUP
Each 10 mL contains:
200 mg guaifenesin
DATE OF APPROVAL: 19 JANUARY 2022
Page 1 of 8
PROFESSIONAL INFORMATION FOR BENYLIN WET COUGH MENTHOL
SCHEDULING STATUS:
S0
1.
NAME OF THE MEDICINE
Benylin Wet Cough Menthol syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL contains:
Guaifenesin
200 mg
_Excipients with known effect: _
Preservative:
Sodium benzoate (E211)
0,2 % _m/v_.
Contains alcohol: Ethyl alcohol 95 %
9,5 % _v/v_
Contains sugar: Each 10 mL contains 2,0 g sucrose and 5,0 mL glucose.
Contains sweetener: Each 10 mL contains 30 mg saccharin sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup.
A reddish brown, syrupy liquid with a strong peppermint-caramel odour
and taste.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alleviation of cough.
Johnson & Johnson (Pty) Ltd
BENYLIN WET COUGH MENTHOL SYRUP
Each 10 mL contains:
200 mg guaifenesin
DATE OF APPROVAL: 19 JANUARY 2022
Page 2 of 8
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Shake the bottle before use.
Adults:
10 mL – 20 mL (two – four medicine measures) every 4 hours.
If symptoms persist a doctor should be consulted.
For oral use only.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to guaifenesin or to any of the other ingredients in
Benylin Wet Cough Menthol
(see section 6.1).
•
Pregnancy and lactation (see section 4.6).
•
Patients with acute porphyria.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Benylin Wet Cough Menthol should not be taken for persistent or
chronic cough, such as occurs
with asthma, or where cough is accompanied by excessive secretions,
unless directed by a
physician.
A persistent cough may be a sign of a serious condition. If cough
persists for more than 7 days,
tends to recur, or is accompanied by a fever, rash, or persistent
headache, a doctor should be
consulted.
BENYLIN WET COUGH MENTHOL CONTAINS SUGAR: SUCROSE AND GLUCOSE
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose malabsorption or