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| Product NDC Code | 83348-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Anesthetic lozenges raspberry flavour |
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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 | 858664 | ||||
| Application Number | part356 | ||||
| Labeler Name | PRASON FOODS | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzocaine 15 mg Menthol 2.6 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 two 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 Acesulfame k, Allura Red AC (FD & Red No.40), Citric acid, Liquid glucose, Raspberry flavor, Sucrose, Tartaric acid 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 occasional minor irritation, pain, sore throat and sore mouth.
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Anesthetic Lozenges Raspberry flavour Benzocaine, Menthol DEXTROSE, UNSPECIFIED FORM SUCROSE ACESULFAME POTASSIUM TARTARIC ACID CITRIC ACID MONOHYDRATE FD&C RED NO. 40 WATER BENZOCAINE BENZOCAINE MENTHOL MENTHOL NO
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.Product label image description image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information Store at room temperature Protect from moisture. TEMPER EVIDENT PACKAGING. DO NOT USE IF OUTER BOX OR BLISTER IS OPENED OR DAMAGED.
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.Warning Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduced 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, grey, or blue colored skin (Cyanosis) Headache Rapid heart ache Shortness of breath Dizziness or light headedness Fatigue or lack of energy Sore throat warning If sore throat is severe, persists 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. Do not use For teething In children under 5 years of age Stop use and ask doctor if Sore mouth symptoms do not improve in 7 days. 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 Poison Control Center right away. Allergy alert : Do not use this product if you have a history of allergy to local anesthetic such as procaine, butacaine, benzocaine, or other "caine" anesthetics
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