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| Product NDC Code | 27017-021 | ||||
|---|---|---|---|---|---|
| Drug Name | Xlear cough drops (green apple) |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| RxCUI drug identifier | 637117 | ||||
| Application Number | part341 | ||||
| Labeler Name | Xlear 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.4.0mg of Menthol (per drop)
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.Adults and children over five - Slowly dissolve one drop every two hours as needed or as directed by a physician. Children under five - Consult your physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Alfalfa, Isomalt, Malic Acid, Natural Apple Flavor, Stevia, Titanium Dioxide, Xytitol
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.Temporarily soothes an irritated or sore throat
Purpose
Information about the drug product’s indications for use.Cough Suppressant / Oral Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Xlear Cough Drops (Green Apple) Menthol XYLITOL MALIC ACID STEVIA LEAF ISOMALT MENTHOL MENTHOL TITANIUM DIOXIDE ALFALFA none
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.label
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Mfg. in a facility that processes dairy, peanut, almond, walnut, nutmeg, pecan, and soy protein.
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.If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore throat symptoms do not improve in 7 days, see your doctor promptly.
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