Dyclonine hydrochloride

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Dyclonine hydrochloride is a local anesthetic that is FDA approved for the treatment of pain,minor irritation,sore mouth,sore throat. Common adverse reactions include rash, Urticaria.

• For the temporary relief of the following occasional mouth and throat symptoms:

• Pain
• Minor irritation
• Sore mouth
• Sore throat

There is limited information regarding Off-Label Guideline-Supported Use of Dyclonine hydrochloride in adult patients.

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dyclonine hydrochloride in adult patients.

• For the temporary relief of the following occasional mouth and throat symptoms:

• Pain
• Minor irritation
• Sore mouth
• Sore throat

There is limited information regarding Off-Label Guideline-Supported Use of Dyclonine hydrochloride in pediatric patients.

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dyclonine hydrochloride in pediatric patients.

There is limited information regarding Dyclonine hydrochloride Contraindications in the drug label.

Stop use and ask a doctor if

• Sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting

• Sore mouth symptoms last more than 7 days, or irritation, pain, or redness continues or worsens

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

There is limited information regarding Clinical Trial Experience of Dyclonine hydrochloride in the drug label.

There is limited information regarding Postmarketing Experience of Dyclonine hydrochloride in the drug label.

There is limited information regarding Dyclonine hydrochloride Drug Interactions in the drug label.

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dyclonine hydrochloride in women who are pregnant.

There is no FDA guidance on use of Dyclonine hydrochloride during labor and delivery.

There is no FDA guidance on the use of Dyclonine hydrochloride with respect to nursing mothers.

There is no FDA guidance on the use of Dyclonine hydrochloride with respect to pediatric patients.

There is no FDA guidance on the use of Dyclonine hydrochloride with respect to geriatric patients.

There is no FDA guidance on the use of Dyclonine hydrochloride with respect to specific gender populations.

There is no FDA guidance on the use of Dyclonine hydrochloride with respect to specific racial populations.

There is no FDA guidance on the use of Dyclonine hydrochloride in patients with renal impairment.

There is no FDA guidance on the use of Dyclonine hydrochloride in patients with hepatic impairment.

There is no FDA guidance on the use of Dyclonine hydrochloride in women of reproductive potentials and males.

There is no FDA guidance one the use of Dyclonine hydrochloride in patients who are immunocompromised.

• Oral

There is limited information regarding Monitoring of Dyclonine hydrochloride in the drug label.

There is limited information regarding IV Compatibility of Dyclonine hydrochloride in the drug label.

There is limited information regarding Chronic Overdose of Dyclonine hydrochloride in the drug label.

There is limited information regarding Dyclonine hydrochloride Pharmacology in the drug label.

There is limited information regarding Dyclonine hydrochloride Mechanism of Action in the drug label.

There is limited information regarding Dyclonine hydrochloride Structure in the drug label.

There is limited information regarding Pharmacodynamics of Dyclonine hydrochloride in the drug label.

There is limited information regarding Pharmacokinetics of Dyclonine hydrochloride in the drug label.

There is limited information regarding Nonclinical Toxicology of Dyclonine hydrochloride in the drug label.

There is limited information regarding Clinical Studies of Dyclonine hydrochloride in the drug label.

There is limited information regarding Dyclonine hydrochloride How Supplied in the drug label.

There is limited information regarding Dyclonine hydrochloride Storage in the drug label.

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• Adults and children 6 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor. Do not take more than 10 lozenges per day.

• Children under 6 years of age: ask a dentist or doctor.

• Alcohol-Dyclonine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

• SUCRETS BLACK CHERRY

The contents of this FDA label are provided by the National Library of Medicine.