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| Product NDC Code | 50804-377 | ||||
|---|---|---|---|---|---|
| Drug Name | Sore throat |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | M022 | ||||
| Labeler Name | Good Sense (Geiss, Destin & Dunn, 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 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 6 years of age and older apply to affected area (one spray) allow to remain in place for at least 15 seconds, then spit out use every 2 hours as directed by a doctor or dentist children under 12 years of age should be supervised in the use of this product children under 6 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, glycerin, methol, purified water, saccharin sodium anhydrous
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 sore throat, pain, sore mouth, pain associated with canker sores, minor mouth irritation
Purpose
Information about the drug product’s indications for use.Purpose Oral Anesthetic/Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Sore Throat Phenol PHENOL PHENOL GLYCERIN WATER SACCHARIN SODIUM FD&C GREEN NO. 3 D&C GREEN NO. 5 D&C YELLOW NO. 10 MENTHOL
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 Fast Relief Sore Throat Spray Phenol 1.4% Oral Anesthetic/Analgesic Relieves sore throat alcohol-free aspirin-free sugar-free Menthol Flavor FL OZ (mL) *Compare to the Active Ingredient of Chloraseptic® *This product is not manufactured or distributed by Prestige Brands, distributor of Chloraseptic®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR TORN. Distributed by: Perrigo Direct, Inc. Peachtree City, GA 30269 www.PerrigoDirect.com
Product Label GOOD SENSE Sore Throat Spray Phenol 1.4%
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. In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) 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 20º-25ºC (68º-77ºF). Do not refrigerate.
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? Call 1-877-753-3935 Monday-Friday 9AM-5PM 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 a doctor if sore mouth symptoms do not improve in 7days 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 dose.
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 a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor. When using this product, do not exceed recommended dose. Stop use and ask a doctor if sore mouth symptoms do not improve in 7days irritation, pain or redness persists or worsens swelling, rash or fever develops 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 a Posion Control Center (1-800-222-1222) 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