Otc - Active Ingredient
4.0 mg of menthol (per drop)
Xlear Cough Drops (black Cherry)
FDA Label NDC 27017-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xlear Inc. for the product Xlear Cough Drops (black Cherry) (NDC 27017-020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, inactive ingredient, dosage & administration, warnings, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Cough Suppressant / Oral Anesthetic
Indications & Usage
Temporarily soothes an irritated or sore throat
Inactive Ingredient
Bett Juice, Isomalt, Malic Acid, Natural Cherry Flavor, Stevia, Titanium Dioxide, Xylitol
Dosage & Administration
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.
Warnings
If sore throat is severe, persists for more than 2days, 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Safety Information
Allergen Information: Mfg. in a facility that processes dairy, peanut, almond, walmut, nutmeg, pecan and soy protein.
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