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| Product NDC Code | 54859-801 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tusnel |
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| Type | Brand | ||||||
| Pharm 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] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 1251296 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (In each tablet) Purpose Dextromethorphan HBr ................... 30 mg ................... Cough Suppressant Guaifenesin .................................. 400 mg .................. Expectorant Pseudoephedrine HCl .................... 60 mg .................... Nasal Decongestant
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions: Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor. adults and children 12 years of age and over take 1 tablet every 6 hours children 6 to under 12 years of age take 1/2 tablet every 6 hours children under 6 years of age ask a doctor
| adults and children 12 years of age and over | take 1 tablet every 6 hours |
| children 6 to under 12 years of age | take 1/2 tablet every 6 hours |
| children under 6 years of age | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: FD and C Blue No. 1, FD and C Blue No. 2, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate type B, titanium dioxide.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Other Information Store at controlled room temperature 20-25 degrees C (68-77 degrees F); excursions permitted to 15-30 degrees C (59-86 degrees F) Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering
Purpose
Information about the drug product’s indications for use.Uses temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive temporary relief of cough due to minor throat and bronchial irritation helps to control reflex that causes coughing
Spl product data elements
Usually a list of ingredients in a drug product.Tusnel Dextromethorphan HBr, Guaifenesin, Pseudoephedrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE FD&C BLUE NO. 2 FD&C BLUE NO. 1 ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE WATER SODIUM STARCH GLYCOLATE TYPE B POTATO TITANIUM DIOXIDE TUSNEL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.TusnelTabLabel
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you are now taking a prescription monamine 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 you are taking a prescription drug that contains on MAOI, ask your doctor or pharmacist before taking this product.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1-866-595-5598
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to the enlargement of the prostate gland a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition. When using this product do not exceed recommended dosage. Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days or accompanied by fever cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API