Otc - Active Ingredient
4.0 mg of Menthol (per drop)
Xlear Cough Drops (honey Lemon)
FDA Label NDC 27017-022
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 (honey Lemon) (NDC 27017-022). 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, dosage & administration, warnings, otc - keep out of reach of children, other safety information, inactive ingredient, 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
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 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
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, walnut, nutmeg, pecan, and soy protein.
Inactive Ingredient
cinnamon bark oil, clove bud oil, eucalyptus radiata leaf oil, isomalt, lemon peel oil, pectin, peppermint aerial parts oil, rosemary leaf oil, stevia leaf extract, water
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