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  5. Label Information: Libi Air Virlaza Dextromethorphan Cough Suppressant

FDA Label for Libi Air Virlaza Dextromethorphan Cough Suppressant

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (PER ML)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREASTFEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION:
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS:
    14. PACKAGE LABELING:

Libi Air Virlaza Dextromethorphan Cough Suppressant Product Label

The following document was submitted to the FDA by the labeler of this product Libi Pharm 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.

Drug Facts




Active Ingredient (Per Ml)



Dextromethorphan 10 mg


Purpose



Cough suppressant


Uses



Temporarily calms Ê cough due to minor throat and bronchial irritation associated with the common cold.


Warnings




Do Not Use



  • this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Stop Use And Ask A Doctor If



  • cough lasts more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. Persistent cough may be a sign of a serious condition.

If Pregnant Or Breastfeeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact Poison ControlCenter right away.


Directions



Adults and children 12 years and overDissolve 1mL in 50 mL of water and take by mouth every 4 hours. Do not take more than 6 mL in 24 hours.
Children 6 to under 12 years of ageDissolve 0.5 mL in 25 mL of water and take by mouth every 4 hours. Do not take more than 3 mL in 24 hours.
Children under 6 years of ageConsult a doctor


Other Information:



  • Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from light.

Inactive Ingredients



basil extract, ethanol, eucalyptus extract, peppermint extract, pine extract, sage extract, sodium selenite, zinc gluconate


Questions Or Comments:



1 (347) 767-6834


Package Labeling:



Label - Label

Label - Label


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