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| Product NDC Code | 53041-615 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Childrens tussnex multi-symptom cold |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 | LIQUID | ||||||
| RxCUI drug identifier | 1043543 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Guardian Drug Company | ||||||
| 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 5 mL) Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 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 take more than 6 doses in any 24 hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Age Dose children 6 years to under 12 years 10 mL every 4 hours children 4 years to under 6 years 5 mL every 4 hours children under 4 years do not use
| Age | Dose |
| children 6 years to under 12 years | 10 mL every 4 hours |
| children 4 years to under 6 years | 5 mL every 4 hours |
| children under 4 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid anhydrous, D and C red 33, dextrose, edetate disodium, FD and C blue 1, FD and C red 40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum
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 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion due to a cold stuffy nose
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.Childrens Tussnex Multi-symptom cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID D&C RED NO. 33 DEXTROSE EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN METHYLPARABEN POTASSIUM SORBATE PROPYL GALLATE PROPYLENE GLYCOL PROPYLPARABEN SACCHARIN SODIUM WATER SODIUM HYDROXIDE SORBITOL SUCRALOSE XANTHAN GUM
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.PDP compare to active ingredients in Mucinex children's Multi-symptom cold Children's Tussnex Multi-symptom cold Dextromethorphan HBr Cough suppressant Guaifenesin Expectorant Phenylephrine HCl Nasal decongestant Relieves nasal and chest chest congestion Thins and loosens mucus Soothes cough Alcohol free NM
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness. keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness. keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use more than directed Stop use and ask a doctor if your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness. keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information each 5 mL contains: potassium 5 mg, sodium 5 mg store between 15-30 o C (59-86 o F) do not refrigerate dosing cup provided
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 a child who 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 prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness. keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
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