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NDC 54859-0507-04 Tusnel 100 mg/5mL Details
Tusnel 100 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 GUAIFENESIN.
MedlinePlus Drug Summary
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: 54859-0507-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 54859-0507 |
|---|---|
| Product ID | 54859-507_ca45fcf4-a645-4c75-a30b-ca9435a5b5ce |
| Associated GPIs | 43200010000910 |
| GCN Sequence Number | 022210 |
| GCN Sequence Number Description | guaifenesin LIQUID 100 MG/5ML ORAL |
| HIC3 | B3J |
| HIC3 Description | EXPECTORANTS |
| GCN | 02512 |
| HICL Sequence Number | 000271 |
| HICL Sequence Number Description | GUAIFENESIN |
| Brand/Generic | Generic |
| Proprietary Name | Tusnel |
| Proprietary Name Suffix | EX |
| Non-Proprietary Name | Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/5mL |
| Substance Name | GUAIFENESIN |
| Labeler Name | Llorens Pharmaceutical International Division, Inc. |
| Pharmaceutical Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 54859-0507-04 (54859050704)
| NDC Package Code | 54859-507-04 |
|---|---|
| Billing NDC | 54859050704 |
| Package | 118 mL in 1 BOTTLE (54859-507-04) |
| Marketing Start Date | 2019-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.02001 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | TUSNEL-EX 100 MG/5 ML LIQUID |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 77c16288-68c4-476c-995f-86f505663270 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Do not use if you are now taking a prescritpion monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's diesease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescirption drug contains an MAOI, aska doctor or pharmacist before taking this product.
Ask a doctor before use 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
EX
guaifenesin liquid |
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| Labeler - Llorens Pharmaceutical International Division, Inc. (037342305) |