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  5. Label Information: Herbion Naturals Mint Cough Drops

FDA Label for Herbion Naturals Mint Cough Drops

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 - DO NOT USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. GENERAL PRECAUTIONS
    10. INACTIVE INGREDIENT
    11. OTC - QUESTIONS
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Herbion Naturals Mint Cough Drops Product Label

The following document was submitted to the FDA by the labeler of this product Herbion Pakistan (pvt) Ltd. 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, 5.5mg


Otc - Purpose



Purpose:

Cough suppressant / Oral Anesthetic


Indications & Usage



Uses:

  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • for temporary relief of occasional minor irritation, pain, sore mouth and sore throat


Warnings



Sore throat warning:

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


Otc - Ask Doctor



Ask a doctor before use if you have:

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

Otc - Do Not Use



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

Otc - Keep Out Of Reach Of Children



keep out of reach of children


Dosage & Administration



Directions:

  • adults and children 2 years of age and over Dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor
  • children under 2 years of age: consult a physician

General Precautions



Other Information:

  • diabetic patients should not use Herbion drops without the advice of a physician and they should monitor glucose levels closely while taking drops as they may alter blood-glucose levels
  • store in a cool, dry place, below 77°F
  • protect from heat and light

Inactive Ingredient



Inactive Ingredients:

 Natural mint  flavor, Eucalyptus oil, Greater galangal Rhizome, Hyssop, Large-leaf geiger tree Fruit, Licorice Root, Long pepper Fruit, Malabar nut tree Leaf,Cane sugar, Citric acid ,Liquid glucose,Ascorbic Acid


Otc - Questions



Questions or Comments?

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