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NDC 54859-0520-16 Tusnel 10; 100; 30 mg/5mL; mg/5mL; mg/5mL Details
Tusnel 10; 100; 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 CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen (Capital and Codeine, Tylenol with Codeine), aspirin, carisoprodol, and promethazine and as an ingredient in many cough and cold medications. This monograph only includes information about the use of codeine. If you are taking a codeine combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.
Related Packages: 54859-0520-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Codeine
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: 54859-0520-16Last 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: 54859-0520-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 54859-0520 |
|---|---|
| Product ID | 54859-520_3ba8cde8-85c8-4c33-a66c-aacc26fb6146 |
| Associated GPIs | 43997303301225 |
| GCN Sequence Number | 000728 |
| GCN Sequence Number Description | pseudoephed/codeine/guaifen SYRUP 30-10-100 ORAL |
| HIC3 | B4Q |
| HIC3 Description | OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT COMB |
| GCN | 54670 |
| HICL Sequence Number | 035174 |
| HICL Sequence Number Description | PSEUDOEPHEDRINE HCL/CODEINE PHOSPHATE/GUAIFENESIN |
| Brand/Generic | Generic |
| Proprietary Name | Tusnel |
| Proprietary Name Suffix | C |
| Non-Proprietary Name | Codeine Phosphate, Guiafenesin, Pseudoephedrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 10; 100; 30 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Llorens Pharmaceutical International Division |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | CV |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 54859-0520-16 (54859052016)
| NDC Package Code | 54859-520-16 |
|---|---|
| Billing NDC | 54859052016 |
| Package | 473 mL in 1 BOTTLE (54859-520-16) |
| Marketing Start Date | 1995-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 403935ac-5111-4f8b-80ae-1bd47ae774c7 Details
SPL UNCLASSIFIED SECTION
Active Ingredients(in each 5 ml tsp.) Purpose
Codeine Phosphate ................................................. 10 mg .......... Cough Suppressant
Guaifenesin .......................................................... 100 mg .................. Expectorant
Pseudoephedrine HCl ............................................. 30 mg .......... Nasal Decongestant
SPL UNCLASSIFIED SECTION
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves: nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis, cough due to minor bronchial irritation as may occur with the common cold
- temporarily restores freer breathing through the nose
- calms the cough control center and relieves coughing
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.
When using this product
do nol exceed recommended dosage
• may cause or aggravate constipation
SPL UNCLASSIFIED SECTION
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. chronic pulmonary disease or shortness of breath, or who are taking other drugs
- you get nervous, dizzy or sleepless. symptoms do not get better within 7 days or are accompanied by fever. cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions: Follow dosage chartDosage may be repeated every 6 hours. Not to exceed 4 doses in 24-hours. Giving a higher dose
than recommended by a doctor could result in serious side effects for your child. A special measuring
device should be used to give an accurate dose of this product to children under 6 years of age.
| Age | Weight | Dose |
| children 12 years of age and over | 95 lbs and up | Take 2 teaspoonfuls (10 mL) every 6 hours |
| Children 6 to under 12 years of age | 45 lbs to under 95 lbs | Take 1 teaspoonful (5mL) every 6 hours |
| Children under 6 years of age | under 45 lbs | ask a doctor |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| TUSNEL
C
codeine phosphate, guiafenesin, pseudoephedrine hcl liquid |
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| Labeler - Llorens Pharmaceutical International Division (037342305) |