Label: MENTHOL COUGH DROPS- menthol 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 July 29, 2021

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

View All Sections
  • Menthol Cough Drops

    Menthol 5 mg Purpose: Cough suppressant.

  • Purpose

    Cough suppressant

  • Uses

    Temporarily relieves:

    • Cough as may occur with a cold or inhaled irritants.
    • Ocasional minor irritation and sore throat.
  • Warnings

    Sore throat warning if sore throat is severe, persists, for more than 2 days, is accompained or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. This symptoms may be serious.

  • Ask a doctor before use if you have:

    • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema. • Cough accompained by excessive phlegm (mocus).

  • When using this product

    Do not exceed recommended dosage.

  • Keep out of reach of children

  • Stop use and ask a doctor if

    Cough persists for more than 7 days, tends to recur, or is accompained by fever, rash, or persisstent headache. This could be signs of a serious condition.

    Sore throat is severe, or irritation, pain or redness lasts or worsens.

    If pregmant or breast-feeding Ask a health professional before use.

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

  • Directions

    • Adults and children 6 years and older: Disolve 1 drop slowly in the mouth. May be repeated every hour as needed.
    • Children under 6 years: Use only under adult supervision.
  • Other information

    Contains: Soy

  • Inactive Ingredients

    Anhydrous dextrose, citric acid monohydrate, cordia boissieri whole, eucalyptus globulus leaf, FD&C Blue No.1, honey, mint, myrrh, propolis wax, sambucus nigra flower, soy lecithin, sucrose, verbascum densiflorum flower. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

  • Package Label - Menthol Drops

    MentholDrops NDC: 72432-200-01

    MentholDrops

  • INGREDIENTS AND APPEARANCE
    MENTHOL COUGH DROPS 
    menthol pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72432-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.005 g  in 4 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    MYRRH (UNII: JC71GJ1F3L)  
    MINT (UNII: FV98Z8GITP)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    HONEY (UNII: Y9H1V576FH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    VERBASCUM DENSIFLORUM FLOWER (UNII: N7FC535Q3R)  
    CORDIA BOISSIERI WHOLE (UNII: 57NZE56C0Z)  
    SUCROSE (UNII: C151H8M554)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize12mm
    FlavorLIMEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72432-200-0136 g in 1 BLISTER PACK; Type 0: Not a Combination Product07/13/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/13/2021
    Labeler - LA TIA TRINI SA DE CV (814376497)
    Registrant - LA TIA TRINI SA DE CV (814376497)
    Establishment
    NameAddressID/FEIBusiness Operations
    LA TIA TRINI SA DE CV814376497manufacture(72432-200)
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!