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| Product NDC Code | 54305-153 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Cool relief oral anesthetic |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | LOZENGE | ||||||||
| Application Number | part341 | ||||||||
| Labeler Name | Ricola Ag | ||||||||
| 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 (in each drop) Menthol, 8.3 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 6 years and older: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor children under 6 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients extracts of peppermint and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, invert sugar (fructose/dextrose), natural flavor, starch syrup, sugar
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: cough due to a cold or inhaled irritants occasional minor irritation and pain due to sore throat or sore mouth
Purpose
Information about the drug product’s indications for use.Drug Facts Purpose Cough suppressant, Oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.COOL RELIEF ORAL ANESTHETIC MENTHOL MENTHOL MENTHOL SUCROSE Icy Menthol R
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.Image of Cool Relief MFP08S-86.jpg
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.Bulk Label Image of Bulk Label img125 res.jpg
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information protect from heat and moisture
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 Sore throat warnings: 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. These may be serious.
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