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NDC 54859-0603-02 Tusnel DM 2.5; 25; 7.5 mg/mL; mg/mL; mg/mL Details
Tusnel DM 2.5; 25; 7.5 mg/mL; mg/mL; mg/mL
Tusnel DM is a ORAL SOLUTION/ DROPS 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: 54859-0603-02Last 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: 54859-0603-02Last 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: 54859-0603-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 54859-0603 |
|---|---|
| Product ID | 54859-603_a3f45673-555c-46e7-9afe-7e6276f1b327 |
| Associated GPIs | 43997303320973 |
| GCN Sequence Number | 068312 |
| GCN Sequence Number Description | guaifenesin/DM/pseudoephedrine DROPS 2.5-7.5/ML ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 31074 |
| HICL Sequence Number | 000222 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Tusnel DM |
| Proprietary Name Suffix | Pediatric |
| Non-Proprietary Name | Dextromethorphan, Guiafenesin, Pseudoephedrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | ORAL |
| Active Ingredient Strength | 2.5; 25; 7.5 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL |
| 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 54859-0603-02 (54859060302)
| NDC Package Code | 54859-603-02 |
|---|---|
| Billing NDC | 54859060302 |
| Package | 60 mL in 1 BOTTLE, DROPPER (54859-603-02) |
| Marketing Start Date | 1993-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d915eab8-013e-4ce3-b358-0d531e5ca1ba Details
SPL UNCLASSIFIED SECTION
Active Ingredients in each 1 mL (dropperful) Purpose
Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant
Guaifenesin........................25mg................................................Expectorant
Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Do not use in child who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, ask a doctor or pharmacist before giving 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
- 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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| TUSNEL DM
PEDIATRIC
dextromethorphan, guiafenesin, pseudoephedrine hcl solution/ drops |
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| Labeler - Llorens Pharmaceutical International Division (037342305) |