Label: NATURAL HERB COUGH DROPS- menthol herb pastille

  • 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 29, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient:

    • Menthol 4.8 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 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
    • Children under 6 years as a Doctor
  • OTHER SAFETY INFORMATION

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

    caramel color, blend of herb extracts (elderflower, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme. wild thyme) glucose syrup, natural flavors, sucrose

    Back Panel

  • QUESTIONS

    Questions? or to report and adverse event call: 1-833-552-1767

  • PRINCIPAL DISPLAY PANEL

    Back

  • INGREDIENTS AND APPEARANCE
    NATURAL HERB COUGH DROPS 
    menthol herb pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-850
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT (UNII: V95R5KMY2B)  
    HOREHOUND (UNII: K08036XEJV)  
    MELISSA OFFICINALIS FLOWER (UNII: RCU5REA2I1)  
    THYME (UNII: CW657OBU4N)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    SAGE (UNII: 065C5D077J)  
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
    CARAMEL (UNII: T9D99G2B1R)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SUCROSE (UNII: C151H8M554)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    WILD THYME (UNII: KXK6I80R8W)  
    Product Characteristics
    ColorbrownScorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorMENTHOL (Herbs) Imprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-850-0160 in 1 BAG; Type 0: Not a Combination Product05/29/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/29/2023
    Labeler - CVS Pharmacy (062312574)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064manufacture(51316-850) , label(51316-850) , pack(51316-850)
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!