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NDC 54859-0544-16 Tusnel 5; 50; 15 mg/5mL; mg/5mL; mg/5mL Details
Tusnel 5; 50; 15 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: 54859-0544-16Last 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: 54859-0544-16Last 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: 54859-0544-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 54859-0544 |
|---|---|
| Product ID | 54859-544_c018e718-f343-42eb-a069-a51a55c5b0cb |
| Associated GPIs | 43997303320915 |
| GCN Sequence Number | 033849 |
| GCN Sequence Number Description | guaifenesin/DM/pseudoephedrine LIQUID 50-5-15/5 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 53357 |
| HICL Sequence Number | 000222 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Tusnel |
| Proprietary Name Suffix | Pediatric |
| Non-Proprietary Name | Dextromethorphan, Guiafenesin, Pseudoephedrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 5; 50; 15 |
| 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 54859-0544-16 (54859054416)
| NDC Package Code | 54859-544-16 |
|---|---|
| Billing NDC | 54859054416 |
| Package | 473 mL in 1 BOTTLE (54859-544-16) |
| Marketing Start Date | 2006-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 82f447f6-4f1b-4f56-9d7d-ea02adeea88c Details
SPL UNCLASSIFIED SECTION
Active Ingredients(in each 5 ml tsp.) Purpose
Dextromethorphan HBr........5mg..................................................Cough Suppressant
Guaifenesin........................50mg................................................Expectorant
Pseudoephedrine HCl..........15mg..................................................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.
SPL UNCLASSIFIED SECTION
Ask a doctor before use if your child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a cough that occurs with too much phlegm (mucus)
- a persistent or chronic cough such as occurs with asthma
When using this product
- do not exceed recommended dosage
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occurs
- symptoms do not get better within 7 days or accompanied by fever
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions Do not exceed more than 4 doses in any 24-hour period
or as directed by a doctor.
| Age | Weight | Dose |
| Children 6 to under 12 years of age | 45 lbs to under 95 lbs | Take 2 teaspoonfuls (10 mL) every 4 to 6 hours |
| Children 2 to under 6 years of age | 25 lbs to under 45 lbs | Take 1 teaspoonful (5mL) every 4 to 6 hours |
| Children under 2 years of age | Under 25 lbs | ask a doctor |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| TUSNEL
PEDIATRIC
dextromethorphan, guiafenesin, pseudoephedrine hcl liquid |
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| Labeler - Llorens Pharmaceutical International Division (037342305) |