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| Product NDC Code | 68163-703 | ||||
|---|---|---|---|---|---|
| Drug Name | Sore throat |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 198776 | ||||
| Application Number | part356 | ||||
| Labeler Name | Raritan Pharmaceuticals Inc | ||||
| 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(s) Phenol 1.4%
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 12 years of age and older: Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds, and then spit out. ▪ Use every 2 hours or as directed by a doctor or dentist. ▪ Children 6 years to under 12 years of age: should be supervised in the use of this product. ▪ Children under 6 years : Consult a doctor or dentist.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients FD&C Red No. 40, flavor, glycerin, purified water, sucralose Questions or comments? 1-866-467-2748
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.Use(s) for the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.
Purpose
Information about the drug product’s indications for use.Purpose Oral pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.SORE THROAT Phenol PHENOL PHENOL FD&C RED NO. 40 GLYCERIN WATER SUCRALOSE Natural Cherry
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 *Compare to the active ingredient in Chloraseptic ® NDC# 68163-703-06 SORE THROAT SPRAY Phenol/Oral Pain Reliever Fast Acting Numbs on Contact SUGAR-FREE ASPIRIN-FREE NATURAL CHERRY FLAVOR 6 FL OZ (177 mL) Tamper-Evident: Do not use if imprinted shrink band is broken or missing. Distributed by: *This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®. DRx Sore Throat Spray
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 • Check expiration date before using.
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 If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-467-2748
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
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 exceed recommended dosage.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding ask a doctor 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 that accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by doctor.
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