THROAT COAT- menthol pastille

Throat Coat by

Drug Labeling and Warnings

Throat Coat by is a Otc medication manufactured, distributed, or labeled by Phytoneering Extract Solutions GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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

Active Ingredient (in each pastille)                                         Purpose
Menthol 2.5 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .    Oral pain reliever

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.

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.

PRINCIPAL DISPLAY PANEL

Enter section text here

Principal Display Panel image

Carton image

INGREDIENTS AND APPEARANCE

THROAT COAT  
menthol pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13340-5624
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
Acacia (UNII: 5C5403N26O)
Raw Sugar (UNII: 8M707QY5GH)
Maltose Syrup (UNII: 00JKR0NZ8O)
Honey (UNII: Y9H1V576FH)
Fennel Oil (UNII: 59AAO5F6HT)
Cinnamon Bark Oil (UNII: XE54U569EC)
Orange Oil (UNII: AKN3KSD11B)
Peppermint Oil (UNII: AV092KU4JH)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND (T)	Size	18mm
Flavor		Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13340-5624-4	24 in 1 BLISTER PACK

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)