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| Product NDC Code | 54859-606 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tusnel-dm pediatric |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-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-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SOLUTION/ DROPS | ||||||
| RxCUI drug identifier | 2268062 | ||||||
| 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 (1 mL) Dextromethorphan HBr 2.5 mg Guaifenesin 25 mg Phenylephrine HCl 1.25 mg
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. Age Weight Dose Children 2 to under 6 years of age 24-47 lbs Take 2 mL every 4-6 hours Children under 2 years of age Under 24 lbs Ask a doctor
| Age | Weight | Dose |
| Children 2 to under 6 years of age | 24-47 lbs | Take 2 mL every 4-6 hours |
| Children under 2 years of age | Under 24 lbs | Ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.
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.Uses Temporary relief of cough due to minor throat and bronchial irritation Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.
Purpose
Information about the drug product’s indications for use.Purpose Cough suppressant Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Tusnel-DM Pediatric Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID GLYCERIN METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SUCRALOSE
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.image description
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 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
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 Do not use in child whos is 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 child's prescription drug contains an MAOI: ask your doctor or pharmacist before giving this product. 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 a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. When using this product do not exceed the recommended dosage. Stope use and ask doctor if nervousness, dizziness or sleeplessness occurs 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. A persistent cough may be a sign of a serious condition.
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