Label: COUNTERACT COUGH DROPS HONEY LEMON- menthol lozenge

  • 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 January 11, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (in each drop)
    Menthol 7 mg

  • PURPOSE

    Purpose
    Cough suppressant, oral anesthetic

  • INDICATIONS & USAGE

    Uses temporarily relieves:

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

  • 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)
  • 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
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • 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
  • STORAGE AND HANDLING

    Other information

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

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

  • PRINCIPAL DISPLAY PANEL

    image of bag
  • INGREDIENTS AND APPEARANCE
    COUNTERACT  COUGH DROPS HONEY LEMON
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-132
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    HONEY (UNII: Y9H1V576FH)  
    LEMON OIL (UNII: I9GRO824LL)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    SUCROSE (UNII: C151H8M554)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    Coloryellow (Bright Yellow) Scoreno score
    ShapeOVAL (Drop) Size22mm
    FlavorHONEY (Honey Lemon) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-132-3030 in 1 BAG; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/20/2008
    Labeler - Melaleuca, Inc. (139760102)