Throat Coat

Dosage form: pastille
Ingredients: Menthol 2.5mg
Labeler: Phytoneering Extract Solutions GmbH
NDC Code: 13340-5624

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


Warnings
Sore throat warning: If sore throat is severe, accompanied or followed
by fever, headache, rash, swelling, nausea, or vomiting, consult a
doctor promptly. If sore mouth symptoms do not improve in 7 days, or if
irritation, pain, or redness persists or worsens, see your dentist or
doctor 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.

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.

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THROAT COAT  
menthol pastille
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13340-5624
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol2.5 mg
Inactive Ingredients
Ingredient NameStrength
Acacia 
Raw Sugar 
Maltose Syrup 
Honey 
Fennel Oil 
Cinnamon Bark Oil 
Orange Oil 
Peppermint Oil 
Product Characteristics
ColorbrownScoreno score
ShapeROUND (T) Size18mm
FlavorImprint CodeT
Contains    
Packaging
#Item CodePackage Description
1NDC:13340-5624-424 PASTILLE (LOZENGE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/26/2005
Labeler - Phytoneering Extract Solutions GmbH (344281931)

Revised: 06/2010
 
Phytoneering Extract Solutions GmbH

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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