FDA Label for Throat Coat
View Indications, Usage & Precautions
Throat Coat Product Label
The following document was submitted to the FDA by the labeler of this product Phytoneering Extract Solutions Gmbh. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Warnings
WarningsSore throat warning: If sore throat is severe, accompanied or followedby fever, headache, rash, swelling, nausea, or vomiting, consult adoctor promptly. If sore mouth symptoms do not improve in 7 days, or ifirritation, pain, or redness persists or worsens, see your dentist ordoctor promptly. Do not exceed recommended dosage.If pregnant or breastfeeding, ask a health professional before use.Keep this and all drugs out of the reach of children.
Otc - Active Ingredient
Active Ingredient (in each pastille) Purpose
Menthol 2.5 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Oral pain reliever
Otc - Purpose
Uses: temporarily relieves occasional minor irritation, pain, sore mouth, sore throat
Dosage & Administration
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 Ingredient
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.
Otc - Do Not Use
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.
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