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Xlear cough drops (honey lemon) - Medication Information

Product NDC Code 27017-022
Drug Name

Xlear cough drops (honey lemon)

Type Brand
Active Ingredients
Menthol 4 mg/1
Route ORAL
Dosage Form LOZENGE
RxCUI drug identifier 637117
Application Number part341
Labeler Name Xlear Inc.
Packages
Package NDC Code Description
27017-022-01 30 lozenge in 1 box (27017-022-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
4.0 mg 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.
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

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 (Honey Lemon) Menthol MENTHOL MENTHOL XYLITOL ISOMALT HONEY CURCUMA LONGA LEAF TITANIUM DIOXIDE MALIC ACID STEVIA LEAF none Lemon

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.
Allergen Information: 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