FDA Label for Dextabs
View Indications, Usage & Precautions
Dextabs Product Label
The following document was submitted to the FDA by the labeler of this product Dxm Pharmacuetical, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
(in each tablet) Dextromethrophan HBr 15 mg
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
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