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| Product NDC Code | 0904-6305 | ||||
|---|---|---|---|---|---|
| Drug Name | Sore throat cherry |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M013 | ||||
| Labeler Name | Major Pharmaceuticals | ||||
| 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 (one spray). • 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. • Adults and children 6 years of age and older: For each application, spray 5 times. • Children under 12 years of age should be supervised in the use of this product. • Children under 3 years of age : Ask a doctor or dentist.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients FD&C Red # 40, flavor, glycerin, purified water, sucralose
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 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 Anesthetic/Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Sore Throat Cherry Phenol PHENOL PHENOL FD&C RED NO. 40 GLYCERIN WATER SUCRALOSE Cherry Flavor
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 Pane COMPARE TO the active ingredient in CHLORASEPTIC ®* NDC 0904-6305-21 MAJOR ® Cherry flavor Sore Throat Spray Relieves Sore Throat Pain New Sprayer SUGAR- FREE ASPIRIN-FREE GLUTEN-FREE Cherry Flavor 6 FL OZ (177 mL) Tamper-Evident: Do not use i9f imprinted shrink band is broken or missing Distributed By MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic ® . Sore Throat Spray Cherry
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.Drug Facts (continued) Keep out of the reach of children. In case of overdose or accidental poisoning , get medical help or contact a Poison Control Center right away at 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? 1-800-616-2471
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 or dentist 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 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 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