Label: NATURAL HERBAL COUGH DROPS- cough drops pastille

  • NDC Code(s): 11673-144-01
  • Packager: Target Corporation Inc.
  • 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 April 1, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient in each drop Purposes

    Menthol 20mg Cough Suppressant

    Oral anesthetic

  • PURPOSE

    Uses Temporarily relieves:

    • cough as may occur with a cold
    • ocasional minor irritation and sore throat
  • INDICATIONS & USAGE

    Uses Temporarily relieves:

    • cough as may occur with a cold
    • ocasional minor irritation and sore throat

  • WARNINGS

    Warnings

    Sore throat warning: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea and vomiting consult a doctor promptly. If sore mouth symptons do not improve in 7 days see your dentist or doctor promptly. These symptons may be serious.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • cough accompanied by excessive phlegm (mucus)
  • STOP USE

    Stop use and consult a doctor if

    • cough persists more than 7 days, tends to recur or is accompanied by fever, headache, rash or persistent headache. These could be signs of serious conditions.
    • sore throat is severe or irritation, pain or redness last or worsens
    • sore mouth does not improve in 7 days

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • OVERDOSAGE

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 12 years and over: allow 2 drops slowly in mouth one a time. Maybe repeated every 2 hours as necessary or as directed by a doctor.
    • Children under 6 years ask a doctor
  • OTHER SAFETY INFORMATION

    • Store in a cool and dry place
  • INACTIVE INGREDIENT

    GLUCOSE SYRUP, SUCROSE, CARAMEL COLOR, ELDERFLOWER, HONEHOUND, HYSSOP, LEMON BALM, LIDEN FIWER, MALOW, PEPPERMINT, SAGE, THYME, WILD THYME, Natural flavours

  • QUESTIONS

    Questions? or to report and adverse event call: 1-617-848-4560

    Monday to Friday 9AM to 4 PM east

  • PRINCIPAL DISPLAY PANEL

    Panel labels

  • INGREDIENTS AND APPEARANCE
    NATURAL HERBAL COUGH DROPS 
    cough drops pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-144
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    LEMON BALM OIL (UNII: MJ76269K9S)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    LEVOISOMETHADONE (UNII: F16TLI77RN)  
    WILD THYME (UNII: KXK6I80R8W)  
    SAGE (UNII: 065C5D077J)  
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
    HOREHOUND (UNII: K08036XEJV)  
    CARAMEL (UNII: T9D99G2B1R)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    SUCROSE (UNII: C151H8M554)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    THYME (UNII: CW657OBU4N)  
    Product Characteristics
    Colorbrown (with menthol drops) Scorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorMENTHOLImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-144-0150 in 1 BAG; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2020
    Labeler - Target Corporation Inc. (006961700)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064manufacture(11673-144) , label(11673-144) , pack(11673-144)
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