Dyclonine hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
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.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- For the temporary relief of the following occasional mouth and throat symptoms:
- Pain
- Minor irritation
- Sore mouth
- Sore throat
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dyclonine hydrochloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dyclonine hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
- For the temporary relief of the following occasional mouth and throat symptoms:
- Pain
- Minor irritation
- Sore mouth
- Sore throat
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dyclonine hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dyclonine hydrochloride in pediatric patients.
Contraindications
There is limited information regarding Dyclonine hydrochloride Contraindications in the drug label.
Warnings
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.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Dyclonine hydrochloride in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Dyclonine hydrochloride in the drug label.
Drug Interactions
There is limited information regarding Dyclonine hydrochloride Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
- Pregnancy Category
- 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.
Labor and Delivery
There is no FDA guidance on use of Dyclonine hydrochloride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Dyclonine hydrochloride with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Dyclonine hydrochloride with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Dyclonine hydrochloride with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Dyclonine hydrochloride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dyclonine hydrochloride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dyclonine hydrochloride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dyclonine hydrochloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dyclonine hydrochloride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dyclonine hydrochloride in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
Monitoring
There is limited information regarding Monitoring of Dyclonine hydrochloride in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Dyclonine hydrochloride in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Dyclonine hydrochloride in the drug label.
Pharmacology
There is limited information regarding Dyclonine hydrochloride Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Dyclonine hydrochloride Mechanism of Action in the drug label.
Structure
There is limited information regarding Dyclonine hydrochloride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Dyclonine hydrochloride in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Dyclonine hydrochloride in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Dyclonine hydrochloride in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Dyclonine hydrochloride in the drug label.
How Supplied
There is limited information regarding Dyclonine hydrochloride How Supplied in the drug label.
Storage
There is limited information regarding Dyclonine hydrochloride Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
- 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.
Precautions with Alcohol
- Alcohol-Dyclonine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- SUCRETS BLACK CHERRY
Look-Alike Drug Names
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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