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| Product NDC Code | 72854-081 | ||||
|---|---|---|---|---|---|
| Drug Name | Mucinex childrens mighty chews cough |
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| Type | Brand | ||||
| Pharm Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 2683424 | ||||
| Application Number | M012 | ||||
| Labeler Name | RB Health (US) LLC | ||||
| 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.Dextromethorphan HBr 10 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 Directions ■ take every 4 hours or as directed by a doctor ■ chew thoroughly before swallowing adults and children 12 years of age and over 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period children 6 to under 12 years of age 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period children under 6 years of age do not use
| adults and children 12 years of age and over | 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period |
| children 6 to under 12 years of age | 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period |
| children under 6 years of age | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, corn syrup, FD&C red no. 40, flavors, glycerin, malic acid, maltodextrin, pectin, potassium sodium tartrate, purified water, sodium chloride, trisodium citrate (anhydrous), sodium polymetaphosphate, sucralose, sucrose
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 Uses ■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Purpose
Information about the drug product’s indications for use.Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant
Spl product data elements
Usually a list of ingredients in a drug product.Mucinex Childrens Mighty Chews Cough Dextromethorphan Hydrobromide CORN SYRUP GLYCERIN WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PECTIN POTASSIUM SODIUM TARTRATE SUCROSE ANHYDROUS CITRIC ACID ANHYDROUS TRISODIUM CITRATE SUCRALOSE MALIC ACID MALTODEXTRIN SODIUM CHLORIDE SODIUM POLYMETAPHOSPHATE FD&C RED NO. 40 M Mixed Berry
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.NDC 72854-061-16 Children's Mucinex® Cough Suppressant Dextromethorphan HBr 5 mg Age 6+ Mixed Berry Flavor Chewable Tablets Label Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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.If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each chewable tablet contains: potassium 5 mg and sodium 15 mg ■ store in a cool dry place at 20-25°C (68-77°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-MUCINEX (1-866-682-4639)
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 ■ 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. Ask a doctor before use if you have ■ a sodium-restricted diet ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) When using this product ■ do not exceed recommended dosage Stop use and ask a doctor if ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache. These could be signs 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