Version May 2024
Mouth/throat symptoms: Approved ages varies by product; product-specific dosing:
Lozenge 2 mg: Children ≥6 years and Adolescents: Oral topical: Slowly dissolve one lozenge in mouth every 2 hours as needed; maximum daily dose: 10 lozenges/day
Lozenge 2 mg (with menthol 5 mg and pectin 6 mg): Children ≥4 years and Adolescents: Oral topical: Slowly dissolve one lozenge in mouth every 2 hours as needed; maximum daily dose: 10 lozenges/day
Lozenge 3 mg (with menthol 6 mg): Children ≥4 years and Adolescents: Oral topical: Slowly dissolve one lozenge in mouth every 2 hours as needed; maximum daily dose: 10 lozenges/day
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Dyclonine: Drug information")
Cough and mouth/throat symptoms: Oral topical: Lozenge: Slowly dissolve 1 lozenge in mouth every 2 hours as needed (maximum: 10 lozenges/day).
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 and incidences are derived from product labeling unless otherwise specified.
Frequency not defined.
Central nervous system: Feeling hot, localized numbness, localized warm feeling, sensation of cold
Gastrointestinal: Burning sensation of mouth
Hypersensitivity: Hypersensitivity reaction
Local: Local irritation, local pain
Other warnings/precautions:
• Self-medication (OTC use): When used for self-medication (OTC), discontinue use and contact health care provider if sore throat is severe, lasts >2 days, or occurs with or following fever, headache, rash, nausea, or vomiting; sore mouth symptoms lasting for >7 days; irritation, pain, or redness persists or worsens; or swelling, rash or fever develops; cough lasts >7 days, comes back, or occurs with fever or persistent headache. Consult a health care provider before use for cough that lasts or is chronic (eg, cough that occurs with smoking, asthma, emphysema) or cough that occurs with too much mucous.
Dosage forms specific issues:
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.
• Tartrazine: Some formulations may contain FD&C yellow #5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in susceptible individuals, particularly those with aspirin sensitivity.
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities, which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Yes
Topical: Allow lozenges to slowly dissolve in mouth.
Oral: Allow lozenge to slowly dissolve in mouth.
Store at room temperature; avoid storing at high temperature (>38°C [>100°F]).
Temporary relief of pain and minor irritation of mouth and throat (OTC products: FDA approved in ages ≥4 years and adults). Note: Approved ages may vary with products; consult product specific labeling.
Dyclonine may be confused with dicyclomine
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Local anesthetic that produces reversible loss of sensation by preventing or diminishing the conduction of nerve impulses near application site.
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