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| Product NDC Code | 54859-603 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tusnel dm pediatric |
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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 | SOLUTION/ DROPS | ||||||
| RxCUI drug identifier | 1241674 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Llorens Pharmaceutical 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 (dropperful) Purpose Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant Guaifenesin........................25mg................................................Expectorant Pseudoephedrine HCl..........7.5mg..............................................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 periodor as directed by a doctor. Age Weight Dose Children 2 to under 6 years of age 24 -47 lbs Take 2 mL (two dropperfuls) every 4 to 6 hours Children under 2 years of age Under 24 lbs ask a doctor
| Children 2 to under 6 years of age | 24 -47 lbs | Take 2 mL (two dropperfuls) every 4 to 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 citric acid, D and C Red Number 33,FD and C Blue #1, flavor, glycerin, propylene glycol, sodium benzoate, sodium saccharin, water.
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° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature] Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering Oral dosing device enclosed
Purpose
Information about the drug product’s indications for 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.
Spl product data elements
Usually a list of ingredients in a drug product.Tusnel DM Pediatric Dextromethorphan, Guiafenesin, Pseudoephedrine HCl Guaifenesin Guaifenesin PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE FD&C BLUE NO. 1 CITRIC ACID MONOHYDRATE GLYCERIN SODIUM BENZOATE SACCHARIN SODIUM PROPYLENE GLYCOL WATER D&C RED NO. 33 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN
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.tusnelDMPed
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.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 Stop use and ask a doctor if 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.
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
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 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.
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