Active Ingredient (Per Lozenge)
Dyclonine hydrochloride 3 mg
Menthol 6 mg
Sucrets Vapor Cherry Lozenge
FDA Label NDC 63736-925
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Sucrets Vapor Cherry (NDC 63736-925). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (per lozenge), purpose, uses, warnings, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral anesthetic
Cough suppressant
Uses
For temporary relief of occasional:
- minor irritation
- pain
- sore mouth
- sore throat
Warnings
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
Stop Use And Ask A Doctor If
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
- cough lasts more than 7 days, comes back, or occurs with fever, or persistent headache. These could be signs of a serious condition.
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 (1-800-222-1222) right away.
Directions
- do not use more than directed
- adults and children 4 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.
- children under 4 years of age: ask a dentist or doctor
Other Information
- store between 15-30°C (59-86°F)
- use only if lozenge blister seals are unbroken
Inactive Ingredients
acesulfame potassium, ascorbic acid, citric acid, corn syrup, fd&c red no. 40, liquid sucrose, propylene glycol, sodium ascorbate, tartaric acid, water, wild cherry flavor, zinc gluconate
Principal Display Panel
SUCRETS
DYCLONINE / ORAL ANESTHETIC
MENTHOL / COUGH SUPPRESSANT
VAPOR CHERRY
18 LOZENGES
Principal Display Panel Sucrets Dyclonine / Oral Anesthetic Menthol / Cough Suppressantvapor Cherry18 Lozenges (Sucrets Vapor Cherry 63736 925 18 01)
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