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| Product NDC Code | 35418-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Cherry throat relief lozenges |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| RxCUI drug identifier | 824574 | ||||
| Application Number | part356 | ||||
| Labeler Name | Zee Medical | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of cherry throat relief lozenges
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact Poison Control Center right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each lozenge) Benzocaine 15 mg Menthol 3.6 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults and children 5 years and older - allow 1 lozenge to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor. children under 5 years - do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Corn starch, FD&C red no. 40, glucose syrup, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves these symptoms: occasional minor irritation, pain, sore mouth and sore throat
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.cherry throat relief lozenges benzocaine BENZOCAINE BENZOCAINE MENTHOL MENTHOL WATER B
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Zee Medical Cherry Benzocaine 18ct Lozenges
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use for teething in children under 2 years of age
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-245-2898. Monday through Friday, 9AM to 4PM EST
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant of breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness if breath dizziness or lightheadedness fatigue or lack of energy Sore throat warning: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persist or worsens, see your dentist or doctor promptly.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API