Benylin Wet Cough Menthol Syrup

Alleviation of cough.

Shake the bottle before use. Adults: 10 mL u2013 20 mL (two u2013 four medicine measures) every 4 hours. If symptoms persist a doctor should be consulted. For oral use only.

• 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.

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 sucrase-isomaltase insufficiency should not take Benylin Wet Cough Menthol.

Benylin Wet Cough Menthol contains sodium benzoate. An increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).

Benylin Wet Cough Menthol contains sodium. Benylin Wet Cough Menthol contains 114 mg sodium per 10 mL, equivalent to 5,7 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Guaifenesin may interfere with diagnostic measurements of urinary 5-hydroxy-indoleacetic acid or vanillylmandelic acid.

Benylin Wet Cough Menthol should not be used during pregnancy and lactation (see section 4.3).

Benylin Wet Cough Menthol can cause side effects, such as drowsiness and may affect the ability to drive and use machinery. Caution is advised before driving a vehicle or operating machinery until the effects of Benylin Wet Cough Menthol are known.

The safety of guaifenesin is based on available data from clinical trials and adverse drug reactions (ADRs) identified during post-marketing experience. The frequencies are provided according to the following convention:

Very common u22651/10
Common u22651/100 and < 1/10
Uncommon u22651/1,000 and <1/100
Rare u22651/10,000 and <1/1,000
Very rare < 1/10,000
Not known (cannot be estimated from the available data)

System organ class and frequency

Adverse reactions

Immune system disorders

Very rare Hypersensitivity

Nervous system disorders

Not known Drowsiness

Gastrointestinal disorders

Very rare Diarrhoea, nausea, vomiting, upper abdominal pain

Not known Gastrointestinal discomfort

Skin and subcutaneous tissue disorders

Very rare Rash

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of Benylin Wet Cough Menthol is important. It allows continued monitoring of the benefit/risk balance of Benylin Wet Cough Menthol. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8. For further information, please contact the Johnson & Johnson call centre on 0860 410032 (landline).

In large doses, guaifenesin will cause drowsiness, nausea and vomiting. It may also cause renal calculi. Treatment is symptomatic and supportive.