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| Product NDC Code | 67091-267 | ||||
|---|---|---|---|---|---|
| Drug Name | Sore throat relief |
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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 | WinCo Foods, LLC | ||||
| 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 apply to the affected area use every 2 hours allow to remain in place for at least 15 seconds, then spit out age dose adults and children 12 years and over for each application, spray 5 times children 3 to 11 years should be supervised in use of this product for each application, spray 3 times children under 3 years ask a doctor or dentist
| age | dose |
| adults and children 12 years and over | for each application, spray 5 times |
| children 3 to 11 years | should be supervised in use of this product for each application, spray 3 times |
| children under 3 years | ask a doctor or dentist |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alcohol, FD&C red #40, glycerin, natural & artificial flavor, purified water, saccharin sodium
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 Relief Phenol PHENOL PHENOL ALCOHOL FD&C RED NO. 40 GLYCERIN WATER SACCHARIN SODIUM
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®* Instant Acting Sore Throat Relief Phenol/Oral Anesthetic Alcohol 0.10% Relieves Sore Throat Pain Cherry Flavor Artificially Flavored FL OZ (mL) *This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Chloraseptic®. TAMPER EVIDENT: DO NOT USE IF IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN. DISTRIBUTED BY: WINCO FOODS LLC BOISE, ID 83704 *This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic®
Package Label WinCo Foods Sore Throat Relief 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 Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Or to report an adverse event call 800-824-1706 Monday-Friday 9am-4pm MST
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 swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20º-25ºC (68º-77ºF). Do not refrigerate.
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 occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age. When using this product, do not use more than directed. Stop use and ask a doctor if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days difficulty in breathing occurs 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 Poison 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