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| Product NDC Code | 68016-343 | ||||
|---|---|---|---|---|---|
| Drug Name | Sore throat relief menthol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 198776 | ||||
| Application Number | M022 | ||||
| Labeler Name | Chain Drug Consortium | ||||
| 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 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 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, 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 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 Menthol Phenol PHENOL PHENOL D&C GREEN NO. 5 D&C YELLOW NO. 10 FD&C GREEN NO. 3 GLYCERIN WATER SUCRALOSE
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®* Sore Throat Relief Menthol Flavor Fast acting relief of Minor Sore Throat and Mouth Pain Phenol/Oral Anesthetic Sugar-Free Aspirin-Free Gluten-Free Alcohol-Free 6 FL OZ (177 mL) *This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic®. Tamper-Evident: Do not use if imprinted shrink band is broken or missing. DISTRIBUTED BY: Chain Drug Consortium LLC. 3301 N.W. Boca Raton Blvd. Suite 101, Boca Raton FL 33431
Package Label Premier Value Sore Throat Spray Menthol Flavor
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 or accidental poisoning, get medical help or contact a Poison Control Center right away (1-800-222-1222)
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 use more than directed.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information • Store at room temperature • Check expiration date before using
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 • sore mouth symptoms do not improve in 7 days • irritation, pain or redness persists or worsens • swelling, rash or fever develops If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away (1-800-222-1222)
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