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Product NDC Code | 71598-152 | ||||
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Drug Name | Dextabs |
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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 | ||||
RxCUI drug identifier | 2173733 | ||||
Application Number | M013 | ||||
Labeler Name | DXM Pharmacuetical, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Dextromethrophan HBr 15 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 only use this product according to these directions or as directed by a doctor do not exceed 8 tablets in any 24-hour period. this adult product is not intended for use in children under 12 years of age. age dose adults and children 12 years and over take 2 tablets every 6 to 8 hours, as needed children under 12 years do not use
adults and children 12 years and over | |
children under 12 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients magnesium stearate, microcrystalline cellulose, sodium starch glycolate
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 Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
Purpose
Information about the drug product’s indications for use.Purpose Cough suppressant
Spl product data elements
Usually a list of ingredients in a drug product.Dextabs DEXTROMETHORPHAN HYDROBROMIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DEX
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.Product label image description
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.Other information • store at 20-25°C (68-77°F). Do not refrigerate. • TAMPER EVIDENT: Do not use if safety seal under child-resistant cap is broken or missing.
Distributed by: DXM Pharmaceutical, Inc. 2717 Commercial Center Blvd., Suite E200 Katy, TX 77 494 www.RoboCough.com.
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? Call weekdays between 10 a.m. to 4 p.m. CST, at 833-289-7626 or visit our website www.RoboCough.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.
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.Warning 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 cough that is accompanied by excessive phlegm (mucus), or • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema. Stop use and ask a doctor if a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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. (1-800-222-1222)
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