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| Product NDC Code | 69626-0048 | ||||
|---|---|---|---|---|---|
| Drug Name | Nice sore throat spearmint |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | M022 | ||||
| Labeler Name | Leosons Overseas Corp | ||||
| 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 & Purposes Active Ingredients Purposes Phenol 1.4% Oral Anesthetic/ Analgesic
| Phenol 1.4% | Oral Anesthetic/ Analgesic |
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 apply to the affected area allow to remain in place for at least 15 seconds, then spit out use every 2 hours or as directed by a doctor or dentist age dose adults and children 12 years of age and older for each application, spray 5 times children 3 to under 12 years should be supervised in use of this product for each application, spray 3 times children under 3 years of age consult a doctor or dentist
| adults and children 12 years of age and older | for each application, spray 5 times |
| children 3 to under 12 years | |
| children under 3 years of age | consult a doctor or dentist |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients D&C green #5, D&C yellow #10, FD&C green #3, flavor, glycerin, propylene glycol, sodium saccharin, 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 For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.
Purpose
Information about the drug product’s indications for use.Active Ingredients Purposes Phenol 1.4% Oral Anesthetic/ Analgesic
| Phenol 1.4% | Oral Anesthetic/ Analgesic |
Spl product data elements
Usually a list of ingredients in a drug product.NICE SORE THROAT Spearmint Phenol PROPYLENE GLYCOL GLYCERIN D&C GREEN NO. 5 WATER SACCHARIN SODIUM SACCHARIN FD&C GREEN NO. 3 D&C YELLOW NO. 10 PHENOL PHENOL
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.Principal Display Panel SUGAR FREE • ALCOHOL FREE • ASPIRIN FREE N'ICE® P H E N O L / O R A L A N E S T H E T I C Sore Throat Spray Fast acting, long lasting relief of minor sore throat and mouth pain SPEARMINT FLAVOR 6 FL OZ (177 mL) NICE Throat Spearmint
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.Drug Facts
Distributed by: LEOSONS Albany, New York 12205 Made in USA
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 this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information store at room temperature TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-855-452-9500 or email at [email protected]
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 a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops difficulty in breathing occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use more than directed.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or 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 Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. When using this product do not use more than directed. 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 difficulty in breathing occurs If pregnant or breast feeding, ask a health professional before use. Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.
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