Libi Air Virlaza Dextromethorphan Cough Suppressant Liquid
FDA Label NDC 84314-000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Libi Pharm Ltd. for the product Libi Air Virlaza Dextromethorphan Cough Suppressant (NDC 84314-000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient (per ml), purpose, uses, warnings, do not use, stop use and ask a doctor if, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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