Tusnel Diabetic Liquid
FDA Label NDC 54859-505

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 Pharmaceuticals International Division for the product Tusnel Diabetic (NDC 54859-505). 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, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

 Active Ingredients ( in each 5 mL tsp.)                                      Purpose

 Dextromethorphan HBr USP........ 10 mg ................................. Cough Suppressant

 Guaifenesin USP ............. 100 mg ......................................... Expectorant

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Warnings

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or if 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 giving this product.

Otc - Do Not Use

Ask a doctor before use if you have

  • a cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema


    • Stop use and ask a doctor if     cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could b a sign of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Center right away.

Otc - Pregnancy Or Breast Feeding

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

Dosage & Administration

Directions

 Do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.

 Age Dose
 Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
 Under 2 years of age Do not use

Indications & Usage

Uses
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Inactive Ingredient

Inactive Ingredients: anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate and sucralose.

Otc - Questions

Questions or Comments? 1-866-595-5598

Distributed By: Llorens International Division, Miami FL 33165

Package Label.Principal Display Panel

Tusneldiabeticlabel (Tusneldiabetic)

Tusneldiabeticlabel (Tusneldiabetic)

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