Label: COUNTERACT COUGH DROPS HONEY LEMON- menthol lozenge

  • 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 06/11

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

  • ACTIVE INGREDIENT

    Active ingredient (in each drop)
    Menthol 7 mg

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  • PURPOSE

    Purpose
    Cough suppressant, oral anesthetic

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  • INDICATIONS & USAGE

    Uses temporarily relieves:

    • cough associated with a cold or inhaled irritants
    • occasional minor irritation, pain, sore mouth, and sore throat
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  • WARNINGS

    Warnings
    Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

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  • ASK DOCTOR

    Ask a doctor before use if you have

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

    Stop use and ask a doctor if

    • cough persists for more than 1 week, tends to recur, or is accompanied by a 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
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 5 years and over: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor.
    • children under 5 years: ask a doctor
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  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • protect from moisture and heat
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  • INACTIVE INGREDIENT

    Inactive ingredients  ascorbic acid, beta-carotene, corn syrup, honey, lemon oil, sodium ascorbate, sucrose, T40-C3 brand Melaleuca Oil

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  • INGREDIENTS AND APPEARANCE
    COUNTERACT  COUGH DROPS HONEY LEMON
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54473-132
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 7 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASCORBIC ACID  
    BETA CAROTENE  
    CORN SYRUP  
    HONEY  
    LEMON OIL  
    SODIUM ASCORBATE  
    SUCROSE  
    TEA TREE OIL  
    Product Characteristics
    Color yellow (Bright Yellow) Score no score
    Shape OVAL (Drop) Size 22mm
    Flavor HONEY (Honey Lemon) Imprint Code P
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54473-132-30 30 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 05/20/2008
    Labeler - Melaleuca, Inc. (139760102)
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