Label: NATURAL HERB COUGH DROP- menthol lozenge 

  • Label RSS
  • NDC Code(s): 57373-103-01, 57373-103-02
  • Packager: P.S.W. INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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

  • Active Ingredient (in each drop)

    Menthol, 3mg

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  • Purposes

    Cough suppressant, Oral pain reliever

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  • Uses

    temporarily relieves

    • Cough due to minor throat and bronchial irritation with common cold or inhaled irritants
    • ocasional minor irritation or sore throat
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  • Warnings

    Sore throat warnings:

    • if sore throat is severe persists for more than 2 days is acompained or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.These may be serious

    Do not use in children under 6 years of age unless directed by a doctor.

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  • 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 (mucus)
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  • Stop use and ask a doctor if

    • cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of serious condition
    • Sore mouth does not improve in 7 days
    • irritation pain, or redness persists or worsens
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  • Keep out of reach of children.

    Enter section text here

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  • Directions

    • adults and children 6 years and older: dissolve 2 drops slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
    • children under 6 years: ask a doctor
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  • Inactive Ingredients

    Sugar Stevia, Corn Starch, Calcium Carbonate, Liquorice Root, Lotus Root, Bitter Apricot Seed, Fragrant Solomonseal Rhizome,Dwarf Lilyturf Tuber, Figwort Root, Chinese Gall, Talc, Lemongrass Oil, Natural Color, Titanium Dioxide, Palm Wax

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  • Principal Display Panel

    TAKABB

    Fights Coughs Naturally

    Soothes Sore Throats

    Natural Chinese Herb

    Lemongrass

    Menthol

    Flavor

    Natural Herb

    Cough Drops

    Cough Suppressant Throat Drops

    Net0.10 oz. (30 drops)

    PRODUCT OF THAILAND

    TAKABB

    Fights Coughs Naturally

    Soothes Sore Throats

    Natural Chinese Herb

    Lemongrass

    Menthol

    Flavor

    Natural Herb

    Cough Drops

    Cough Suppressant Throat Drops

    Net 0.32 oz. (90 drops)

    PRODUCT OF THAILANDUntitled.jpgUntitledd.jpg

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  • INGREDIENTS AND APPEARANCE
    NATURAL HERB  COUGH DROP
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57373-103
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 3 mg
    Inactive Ingredients
    Ingredient Name Strength
    LICORICE  
    RHUS CHINENSIS ROOT  
    SUCROSE  
    PEPPERMINT OIL  
    STEVIA REBAUDIUNA LEAF  
    STARCH, CORN  
    CALCIUM CARBONATE  
    NELUMBO NUCIFERA ROOT  
    PRUNUS ARMENIACA WHOLE  
    POLYGONATUM ODORATUM WHOLE  
    OPHIOPOGON JAPONICUS ROOT  
    SCROPHULARIA NODOSA ROOT  
    TALC  
    TITANIUM DIOXIDE  
    CARNAUBA WAX  
    WEST INDIAN LEMONGRASS OIL  
    Product Characteristics
    Color brown (GOLDEN BROWN) Score no score
    Shape ROUND (NO) Size 5mm
    Flavor MENTHOL (HERBAL MENTHOL) Imprint Code NO
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57373-103-01 30 in 1 PACKAGE
    2 NDC:57373-103-02 90 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/25/2013
    Labeler - P.S.W. INC. (802789420)
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