Label: COUGH DROPS- menthol pastille

  • NDC Code(s): 83455-206-01
  • Packager: United Natural Foods, 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 May 12, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    • Menthol 5.4 mg cough suppresant oral anesthetic
      Front Panel
  • PURPOSE

    Uses temporarily relieves:

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

    Uses temporarily relieves:

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

  • WARNINGS

    Warnings

    Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • a severe throat accompanied by difficulty in breathing or that last more than 2 days
    • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
  • STOP USE

    Stop use and consult a doctor if

    • sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
  • 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: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
    • Children under 12 years and under do not use
  • OTHER SAFETY INFORMATION

    • Store in a cool and dry place
    • 10 calories per drop
  • INACTIVE INGREDIENT

    • glucose syrup, sucrose

    Back Panel

  • QUESTIONS

    Questions or comments: 1-855-423-2630

  • PRINCIPAL DISPLAY PANEL

    Back

  • INGREDIENTS AND APPEARANCE
    COUGH DROPS 
    menthol pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83455-206
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Coloryellow (Transparent) Scorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorMENTHOLImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83455-206-0130 in 1 BAG; Type 0: Not a Combination Product05/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/12/2023
    Labeler - United Natural Foods, Inc. (943556183)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064manufacture(83455-206) , label(83455-206) , pack(83455-206)
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