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THE ORIGINAL NATURAL HERB COUGH DROPS (Ricola USA Inc.)

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LOZENGE 10 LOZENGE in 1 PACKAGE (63667-923-10) Label Information

Complete THE ORIGINAL NATURAL HERB COUGH DROPS Information

  • Drug Facts

    Purpose

    Cough suppressant, Oral pain reliever


  • Active Ingredient (in each drop)

    Menthol, 5.3 mg


  • Uses

    temporarily relieves:

    • cough due to a cold or inhaled irritants
    • occasional minor irritation and pain due to sore throat or sore mouth

  • Warnings

    Sore throat warnings:

    • if sore throat is severe, persists for more than 2 days, is accompanied 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.

  • Ask doctor before use if you have

    • persistent chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)

  • Stop use and ask a doctor if

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

  • Keep out of reach of children.



  • Directions

    • adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor.
    • children under 6 years: ask a doctor

  • Inactive Ingredients

    color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), natural flavor, starch syrup, sugar
  • INGREDIENTS AND APPEARANCE
    THE ORIGINAL NATURAL HERB COUGH DROPS 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63667-923
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.3 mg
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    CARAMEL (UNII: T9D99G2B1R)  
    Product Characteristics
    Color brown (NUT BROWN) Score no score
    Shape RECTANGLE Size 16mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63667-923-10 10 in 1 PACKAGE; Type 0: Not a Combination Product 01/01/1942
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/1942
    Labeler - Ricola USA Inc. (177265261)
    Establishment
    Name Address ID/FEI Business Operations
    Ricola Ag 485393768 manufacture(63667-923)