The following Structured Product Label (SPL) was submitted to the FDA by Phytoneering Extract Solutions Gmbh for the product Throat Coat (NDC 13340-5624). 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 warnings, otc - active ingredient, otc - purpose, dosage & administration, inactive ingredient, otc - do not use, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient (in each pastille) Purpose
Menthol 2.5 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Oral pain reliever
Uses: temporarily relieves occasional minor irritation, pain, sore mouth, sore throat
Directions For adults and children 2 to 12 years of age: Allow 1 pastille to dissolve slowly in the mouth. May be repeated
every 2 hours as needed or as directed by a dentist or doctor. Children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredients
Organic gum arabic, organic raw cane sugar, Throat Coat® herbal extract
(extractive obtained from a mixture of: licorice root, organic wild cherry bark,
organic bitter fennel fruit, organic cinnamon bark, organic sweet orange peel,
organic slippery elm bark, organic marshmallow root, and licorice root dry
extract), organic maltose syrup, honey, organic peppermint leaf essential oil,
organic sweet orange peel essential oil, organic fennel fruit essential oil,
organic cinnamon bark essential oil, natural vegetable and beeswax glaze.
Other Information
Tamper-evident: Each pastille is individually enclosed in a sealed, imprinted blister. Do not use if the blister unit is open or torn.
Enter section text here
Image Of Principal Display Panel (Principaldisplaypanel)
Image Of Carton (Carton)
* Please review the disclaimer below.
