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| Product NDC Code | 0280-0089 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Alka seltzer plus maximum strength cough chest congestion powerfast fizz |
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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 | TABLET, EFFERVESCENT | ||||||
| RxCUI drug identifier | 2598125 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Bayer Healthcare 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 tablet) Purposes Dextromethorphan hydrobromide 10 mg………….…Cough suppressant 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 Directions do not take more than the recommended dose adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 12 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.anhydrous citric acid, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium bicarbonate, 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 Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold the intensity of coughing helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Spl product data elements
Usually a list of ingredients in a drug product.Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz dextromethorphan hydrobromide, guaifenesin CALCIUM SILICATE DIMETHICONE ANHYDROUS CITRIC ACID DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN POVIDONE POTASSIUM BICARBONATE SUCRALOSE SODIUM BICARBONATE MANNITOL GUAIFENESIN GUAIFENESIN ASP;CandC
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.Carton 24 count Alka Seltzer Plus Maximum Strength Cough & Chest Congestion POWERFAST FIZZ™ Dextromethorphan HBr / Cough Suppressant Guaifenesin/Expectorant 24 EFFERVESCENT TABLETS ASP Cough and Chest Congestion Cool Blueberry Pomegranate 24ct
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.Other information ● each tablet contains: potassium 80 mg; sodium 237 mg ● store at room temperature. 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 or comments Questions or comments? 1-800-986-0369 (Mon - Fri 9AM - 5PM EST)
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. ● if you have ever had an allergic reaction to this product or any of its Ingredients ● in children under 12 years of age Ask a doctor before use if you have ● cough that occurs with excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ● a sodium-restricted diet Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use.
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