Label: THROAT COAT- menthol pastille
Contains inactivated NDC Code(s)
NDC Code(s): 13340-5624-4
- Packager: Phytoneering Extract Solutions GmbH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated June 30, 2010
If you are a consumer or patient please visit this version.
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
- DOSAGE & ADMINISTRATION
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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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)