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  5. Label Information: Counteract Cough Drops Honey Lemon

FDA Label for Counteract Cough Drops Honey Lemon

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT

Counteract Cough Drops Honey Lemon Product Label

The following document was submitted to the FDA by the labeler of this product Melaleuca, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient (in each drop)
Menthol 7 mg


Otc - 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.


Otc - 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)

Otc - 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

Otc - Pregnancy Or Breast Feeding



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


Otc - 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


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