OTC Medication Information: Throat Coat

THROAT COAT — menthol pastille
Phytoneering Extract Solutions GmbH

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 InformationTamper-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 Type HUMAN OTC DRUG Item Code (Source) NDC:13340-5624
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Acacia
Raw Sugar
Maltose Syrup
Honey
Fennel Oil
Cinnamon Bark Oil
Orange Oil
Peppermint Oil
Product Characteristics
Color brown Score no score
Shape ROUND (T) Size 18mm
Flavor Imprint Code T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13340-5624-4 24 PASTILLE (LOZENGE) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 01/26/2005
Labeler — Phytoneering Extract Solutions GmbH (344281931)

Revised: 06/2010 Phytoneering Extract Solutions GmbH

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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