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Tusnel - Medication Information

Product NDC Code 54859-502
Drug Name

Tusnel

Type Brand
Pharm Class Adrenergic alpha-Agonists [MoA],
Sigma-1 Agonist [EPC],
Sigma-1 Receptor Agonists [MoA],
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],
Uncompetitive NMDA Receptor Antagonists [MoA],
alpha-Adrenergic Agonist [EPC]
Active Ingredients
Dextromethorphan hydrobromide 15 mg/5ml
Guaifenesin 200 mg/5ml
Pseudoephedrine hydrochloride 30 mg/5ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 1098227
Application Number part341
Labeler Name Llorens Pharmaceutical International Division
Packages
Package NDC Code Description
54859-502-06 178 ml in 1 bottle (54859-502-06)
54859-502-10 3786 ml in 1 bottle (54859-502-10)
54859-502-16 474 ml in 1 bottle (54859-502-16)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients(in each 5 ml tsp.) Purpose Dextromethorphan HBr........15mg..................................................Cough Suppressant Guaifenesin........................200mg................................................Expectorant Pseudoephedrine HCl..........30mg..................................................Nasal Decongestant

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor. Age Dose Adults and children 12 years of age and over Take 2 teaspoonfuls (10 mL) every 6 hours
AgeDose
Adults and children 12 years of age and over Take 2 teaspoonfuls (10 mL) every 6 hours

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients: artificial grape flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses: temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold helps control reflex that causes coughing helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis).

Purpose

Information about the drug product’s indications for use.
Purpose Cough Suppressant Expectorant Nasal Decongestant

Spl product data elements

Usually a list of ingredients in a drug product.
Tusnel Dextromethorphan, Guiafenesin, Pseudoephedrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Guaifenesin Guaifenesin PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE ASPARTAME CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN POTASSIUM CITRATE POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
tusnelliquidlabel

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or Comments? 1-866-595-5598

Pregnancy or breast feeding

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

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 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. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of prostate gland a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs. Stop use and ask a doctor if 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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API