BENYLIN WET COUGH LIQUID

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Johnson & Johnson (Pty) Ltd û East London

Dosage:

See ingredients

Pharmaceutical form:

LIQUID

Composition:

EACH 10,0 ml LIQUID CONTAINS GUAIFENESIN 200,0 mg

Authorization status:

Registered

Authorization date:

2005-05-09

Patient Information leaflet

Johnson & Johnson (Pty) Ltd
BENYLIN WET COUGH LIQUID
Each 10 mL contains:
200 mg guaifenesin
DATE OF APPROVAL: 20.04.2022
Page 1 of 8
PATIENT INFORMATION LEAFLET FOR BENYLIN WET COUGH
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S0
BENYLIN WET COUGH LIQUID
GUAIFENESIN 200 MG PER 10 ML
CONTAINS SWEETENERS: EACH 10 ML CONTAINS 16 MG SACCHARIN SODIUM AND 13
MG SODIUM
CYCLAMATE.
CONTAINS SUGAR ALCOHOL: EACH 10 ML CONTAINS 4,015 G SORBITOL.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Benylin Wet Cough is available without a doctor’s prescription, for
you to treat a mild illness.
Nevertheless, you still need to use Benylin Wet Cough carefully to get
the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share Benylin Wet Cough 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 is and what it is used for.
2.
What you need to know before you use Benylin Wet Cough.
3.
How to use Benylin Wet Cough.
4.
Possible side effects.
5.
How to store Benylin Wet Cough.
6.
Contents of the pack and other information.
1.
WHAT BENYLIN WET COUGH IS AND WHAT IT IS USED FOR
Johnson & Johnson (Pty) Ltd
BENYLIN WET COUGH LIQUID
Each 10 mL contains:
200 mg guaifenesin
DATE OF APPROVAL: 20.04.2022
Page 2 of 8
Benylin Wet Cough 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
DO NOT USE BENYLIN WET COUGH
•
If you or your child is hypersensitive (allergic) to guaifenesin or
any of the other ingredients
of Benylin Wet Cough (see WHAT BENYLIN WET COUGH CONTAINS).
•
If you are pregnant or breastfeeding (see PREGNANCY, BREASTFEEDING AND
FERTILITY).
•
If you or your child has acute porphyria.
Benylin Wet Cough is not recommended for use in children unde

Summary of Product characteristics

Johnson & Johnson (Pty) Ltd
BENYLIN WET COUGH LIQUID
Each 10 mL contains:
200 mg guaifenesin
DATE OF APPROVAL: 20.04.2022
Page 1 of 8
PROFESSIONAL INFORMATION FOR BENYLIN WET COUGH
SCHEDULING STATUS:
S0
1.
NAME OF THE MEDICINE
Benylin Wet Cough liquid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL contains:
Guaifenesin
200 mg
_Excipients with known effect: _
Preservative: sodium benzoate
0,1 % _m/v_.
Contains sweeteners: Each 10 mL contains 16 mg saccharin sodium and 13
mg sodium
cyclamate.
Contains sugar alcohol: Each 10 mL contains 4,015 g sorbitol.
Alcohol free and colourant free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Liquid.
A clear, colourless to straw-coloured, syrupy liquid with a strawberry
odour and taste.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alleviation of cough.
Johnson & Johnson (Pty) Ltd
BENYLIN WET COUGH LIQUID
Each 10 mL contains:
200 mg guaifenesin
DATE OF APPROVAL: 20.04.2022
Page 2 of 8
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Shake the bottle before use.
Adults and children over 12 years:
10 mL - 20 mL (two - four medicine measures) every 4 hours.
Children 6 – 12 years old:
5 mL – 10 mL (one – two medicine measures) every 4 hours.
Children 4 to under 6 years:
2,5 mL – 5 mL (half - one medicine measure) every 4 hours.
If symptoms persist a doctor should be consulted.
Not recommended for children under 4 years of age.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to guaifenesin or to any of the other ingredients in
Benylin Wet Cough (see section
6.1).
•
Pregnancy and lactation (see section 4.6).
•
Patients with acute porphyria.
•
Not recommended for children under 4 years of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Benylin Wet Cough should not be taken for persistent or chronic cough,
which occurs with smoking,
asthma, emphysema or where cough is accompanied by excessive
secretions except under the
advice and supervision of a doctor. A persistent cough may be a sign
of a serious condition. If cough
persists for more th