Label: THROAT COAT- menthol pastille

  • 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.

Drug Label Information

Updated June 30, 2010

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    image of principal display panel

    Principal Display Panel image

    image of carton

    Carton image







  • INGREDIENTS AND APPEARANCE
    THROAT COAT  
    menthol pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13340-5624
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorbrownScoreno score
    ShapeROUND (T) Size18mm
    FlavorImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13340-5624-424 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!