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| Product NDC Code | 72854-153 | ||||
|---|---|---|---|---|---|
| Drug Name | Mucinex fast-max severe congestion and cough maximum strength |
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| Type | Brand | ||||
| Pharm Class | 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] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1111663 | ||||
| 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.Active ingredients (in each liquid gel) Purposes Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant
| Dextromethorphan HBr 10 mg | |
| Guaifenesin 200 mg | Expectorant |
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 12 capsules in any 24-hour period ■ adults and children 12 years of age and over: take 2 capsules every 4 hours ■ children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C yellow no.10, FD&C blue no. 1, gelatin, glycerin, hypromellose, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, 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.Uses Uses: ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive Temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep
Purpose
Information about the drug product’s indications for use.Dextromethorphan HBr 10 mg....Cough suppressant Guaifenesin 200mg...............................Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Mucinex Fast-Max Severe Congestion and Cough Maximum Strength Dextromethorphan Hydrobromide, Guaifenesin POVIDONE WATER GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED FD&C BLUE NO. 1 D&C YELLOW NO. 10 LECITHIN, SOYBEAN LIGHT MINERAL OIL PROPYLENE GLYCOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GELATIN TITANIUM DIOXIDE SORBITOL SOLUTION GUAIFENESIN GUAIFENESIN HYPROMELLOSES AR08
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.Fast Dissolving Liquid Gels! NDC 72854-126-16 MAXIMUM STRENGTH MUCINEX® FAST-MAX ® 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.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.■ store at 20-25°C (68-77°F) ■ avoid excessive heat
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.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 ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ 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 ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. 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.
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