Label: MENTHOL COUGH DROPS- menthol pastille

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 29, 2021

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  • 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)