Version May 2024
Cough: Oral: 25 mg 3 to 4 times daily as needed.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Clofedanol (Chlophedianol) (United States: Not available): Pediatric drug information")
Cough: Note: Safety and efficacy for the use of cough and cold products in infants and children are limited; the Canadian Paediatric Society warns against the use of these products for respiratory illnesses in infants and children; Health Canada advises against OTC use in infants and children <6 years of age due to the risk of serious and life-threatening adverse effects (including death) and recommends using with caution in pediatric patients ≥6 years of age (CPS 2017; CPS [Goldman 2011]; Health Canada 2021).
Children 2 to <6 years: Oral: 12.5 mg 3 to 4 times daily as needed.
Children 6 to <12 years: Oral: 12.5 to 25 mg 3 to 4 times daily as needed.
Children ≥12 years and Adolescents: Oral: 25 mg 3 to 4 times daily as needed.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Frequency not defined:
Dermatologic: Urticaria
Gastrointestinal: Nausea (larger doses), vomiting (larger doses), xerostomia (larger doses)
Hypersensitivity: Hypersensitivity reaction
Nervous system: Drowsiness (larger doses), excitement, hyperirritability, nightmares, vertigo (larger doses)
Ophthalmic: Visual disturbance (larger doses)
Concerns related to adverse effects:
• CNS depression: May cause CNS depression at large doses, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Special populations:
• Debilitated patients: Use with caution in patients who are sedated or debilitated.
Other warnings/precautions:
• Appropriate use: May not be appropriate for patients with a productive cough.
Safety and efficacy for the use of cough and cold products in infants and children are limited; the Canadian Paediatric Society warns against the use of these products for respiratory illnesses in infants and children; Health Canada advises against OTC use in infants and children <6 years of age due to the risk of serious and life-threatening adverse effects (including death) and recommends using with caution in pediatric patients ≥6 years of age. OTC products containing certain active ingredients have been relabeled to indicate not for use in children <6 years of age (CPS 2017; CPS [Goldman 2011]; Health Canada 2021).
Not available in the US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Syrup, Oral, as hydrochloride:
Ulone: 25 mg/5 mL
Oral: Administer liquid formulations with an accurate measuring device; do not use a household teaspoon (overdosage may occur).
Note: Not available in the US
Cough: Symptomatic relief of cough
None known.
There are no known significant interactions.
Centrally acting non-opioid antitussive with comparable cough suppressant potency, slower onset of maximum effect, and longer duration of action than that of opioids; has moderate local anesthetic effects with some anticholinergic action.
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