Label: THIEVES COUGH DROP- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 10, 2023

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  • ACTIVE INGREDIENT

    Menthol 8mg

  • PURPOSE

    Cough Suppressant / Oral Anesthetic

  • INDICATIONS & USAGE

    Temporarily relieves:

    - cough due to a cold

    - occasional minor irritation or sore throat

  • WARNINGS

    Sore Throat Warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, or vomiting, consult a doctor promptly. These symptoms may be serious.

  • ASK DOCTOR/PHARMACIST

    - persistent or chronic cough such as occurs with smoking, asthma or emphysema

    - cough accompanied by excessive phlegm (mucus)

  • STOP USE

    - cough persists for more than 1 seek, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    - sore mouth does not improve in 7 days

    - irritation, pain, or redness persists or worsens

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health care professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    - Adults and children 5 years of age: dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed.

    - Children under 5 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    - store at room temperature. Keep out of direct sunlight.

    - 5 calories per drop

  • INACTIVE INGREDIENT

    cinnamon bark oil, clove bud oil, eucalyptus radiata leaf oil, isomalt, lemon peel oil, pectin, peppermint aerial parts oil, rosemary leaf oil, stevia leaf extract, water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    THIEVES COUGH DROP 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83240-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 mg
    Inactive Ingredients
    Ingredient NameStrength
    LEMON OIL (UNII: I9GRO824LL)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    ISOMALT (UNII: S870P55O2W)  
    PECTIN (UNII: 89NA02M4RX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    CLOVE OIL (UNII: 578389D6D0)  
    EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)  
    Product Characteristics
    ColorredScorescore with uneven pieces
    ShapeOVALSize22mm
    FlavorMENTHOLImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83240-001-0130 in 1 BOX; Type 0: Not a Combination Product12/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/17/2019
    Labeler - Young Living (836136630)
    Establishment
    NameAddressID/FEIBusiness Operations
    Primrose Candy Company005086855manufacture(83240-001)
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