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NDC 54859-0506-04 Tusnel 10; 100 mg/5mL; mg/5mL Details
Tusnel 10; 100 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, Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
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: 54859-0506-04Last 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: 54859-0506-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 54859-0506 |
|---|---|
| Product ID | 54859-506_a6d82b30-2a69-4ab0-ac2a-9f1014fe3df2 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Tusnel |
| Proprietary Name Suffix | SF |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 10; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Llorens Pharmaceutical International Division, Inc. |
| Pharmaceutical Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 54859-0506-04 (54859050604)
| NDC Package Code | 54859-506-04 |
|---|---|
| Billing NDC | 54859050604 |
| Package | 118 mL in 1 BOTTLE (54859-506-04) |
| Marketing Start Date | 2019-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cb43b4df-5ccc-416e-abcd-98f079b3f2bb Details
SPL UNCLASSIFIED SECTION
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 us if you have
- 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 lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| TUSNEL
SF
dextromethorphan hbr, guaifenesin liquid |
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| Labeler - Llorens Pharmaceutical International Division, Inc. (037342305) |
| Registrant - Llorens Pharmaceutical International Division, Inc. (037342305) |