Adults and Children aged 12 years and over:
One 10 ml dose of syrup 4 times a day.
Maximum daily dose: 40 ml syrup.
Children under 12 years:
BENYLIN CHESTY COUGHS (ORIGINAL) is contraindicated in children under the age of 12 years (see section 4.3).
The Elderly:
As for adults above (see Pharmacokinetics - The elderly).
Hepatic dysfunction
Caution should be exercised if moderate to severe hepatic dysfunction is present (see Pharmacokinetics - Hepatic dysfunction).
Renal dysfunction
It may be prudent to increase the dosage interval in subjects with moderate to severe renal failure (see Pharmacokinetics - Renal dysfunction).
Do not exceed the stated dose.
Keep out of the sight and reach of children.
4.3 Contraindications
BENYLIN CHESTY COUGHS (ORIGINAL) is contraindicated in individuals with known hypersensitivity to Diphenhydramine or L-menthol or to any of the excipients listed in section 6.1.
BENYLIN CHESTY COUGHS (ORIGINAL) should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment (see section 4.5).
Not to be used in children under the age of 12 years.
4.4 Special warnings and precautions for use
This product may cause drowsiness. If affected individuals should not drive or operate machinery.
This product should not be used to sedate a child.
Diphenhydramine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, opioid analgesics, antipsychotics and tranquilizers. Alcoholic beverages should be avoided while taking this medicine (see section 4.5).
Do not use with any other product containing diphenhydramine, including topical formulations used on large areas of skin.
Subjects with hepatic disease or moderate to severe renal dysfunction should exercise caution when using this product (see Pharmacokinetics - Renal/Hepatic Dysfunction).
Patients with the following conditions should be advised to consult a physician before using this medicine:
• A chronic or persistent cough such as occurs with chronic bronchitis or emphysema, acute or chronic asthma, or where cough is accompanied by excessive secretions
• Susceptibility to angle-closure glaucoma
• Prostatic hypertrophy and/or urinary retention
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine
This product contains Ponceau 4R (E124) red colouring which may cause allergic reactions.
This medicine contains 16.62 mg sodium (main component of cooking/table salt) in each 5 ml. This is equivalent to 0.83% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 0.22 mg benzyl alcohol in each 5ml. Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
This medicine contains 10 mg benzoic acid in each 5 ml.
This medicine contains 0.26 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.