Tusnel Liquid
FDA Label NDC 54859-517

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division, Inc. for the product Tusnel (NDC 54859-517). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

In each 5 mL

Dextromethorphan HBr - 20 mg

Guaifenesin - 400 mg

Phenylephrine HCl - 10 mg

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Indications & Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold
  • nasal congestion •cough due to minor throat and bronchial irritation

Warnings

Warnings

Do not use if you are taking a 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 using this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargment of prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    • Stop use and ask a doctor if you get

    • nervousness, dizziness, or sleeplessness occur
    • cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a doctor before using this product

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

Dosage & Administration

Directions: Do not exceed 6 doses in 24 hour

 Age Dose
 Adults and children over 12 years of age Take 5 mL (one teaspoonful) every 4 hours
 Children under 12 years of age Ask a doctor

Inactive Ingredient

Inactive ingredients:artificial and natural flavor, citric acid, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Otc - Questions

Questions or Comments? 1-866-595-5598

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Tusneldm (Tusneldm)

Tusneldm (Tusneldm)

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