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NDC 54859-0502-16 Tusnel 15; 200; 30 mg/5mL; mg/5mL; mg/5mL Details
Tusnel 15; 200; 30 mg/5mL; mg/5mL; mg/5mL
Tusnel is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 54859-0502-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 54859-0502-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 54859-0502-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 54859-0502 |
|---|---|
| Product ID | 54859-502_5d562cdd-a7fd-493b-b0dd-caf34e61d591 |
| Associated GPIs | 43997303320990 |
| GCN Sequence Number | 060480 |
| GCN Sequence Number Description | guaifenesin/DM/pseudoephedrine SOLUTION 200-15-30 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 26642 |
| HICL Sequence Number | 000222 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Tusnel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan, Guiafenesin, Pseudoephedrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 15; 200; 30 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Llorens Pharmaceutical International Division |
| Pharmaceutical 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] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 54859-0502-16 (54859050216)
| NDC Package Code | 54859-502-16 |
|---|---|
| Billing NDC | 54859050216 |
| Package | 474 mL in 1 BOTTLE (54859-502-16) |
| Marketing Start Date | 2006-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 805dc611-355a-4af5-bf19-464c3290c5c6 Details
SPL UNCLASSIFIED SECTION
Active Ingredients(in each 5 ml tsp.) Purpose
Dextromethorphan HBr........15mg..................................................Cough Suppressant
Guaifenesin........................200mg................................................Expectorant
Pseudoephedrine HCl..........30mg..................................................Nasal Decongestant
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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).
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| TUSNEL
dextromethorphan, guiafenesin, pseudoephedrine hcl liquid |
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| Labeler - Llorens Pharmaceutical International Division (037342305) |