Active Ingredient
(in each tablet) Dextromethrophan HBr 15 mg
Dextabs Tablet
FDA Label NDC 71598-152
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dxm Pharmacuetical, Inc. for the product Dextabs (NDC 71598-152). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warning, dosage & administration, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Uses
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
Warning
Do not useif 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 ifyou 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 ifa 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)
Dosage & Administration
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 |
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.
Inactive Ingredients
magnesium stearate, microcrystalline cellulose, sodium starch glycolate
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.
Other
Distributed by:
DXM Pharmaceutical, Inc. 2717 Commercial Center Blvd., Suite E200
Katy, TX 77 494
www.RoboCough.com.
Product Label
Image Description (Product Label Updated)
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