Desgen Dm Tabs
FDA Label NDC 52083-648
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Desgen Dm Tabs (NDC 52083-648). 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 drug facts, active ingredients (in each tablet), purpose, otc - keep out of reach of children, indications & usage, warnings, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Tablet)
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Pseudoephedrine HCl, 30 mg
Purpose
Antitussive
Expectorant
Nasal Decongestant
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Indications & Usage
Uses • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants • helps loosen phlegm and thin bronchial secretions to make coughs more productive • temporarily relieves nasal congestion
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.
Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by excessive phlegm (mucus)
When using this product • do not exceed recommended dosage
Stop use and ask a doctor if • 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 • symptoms do not improve within 7 days or are accompanied by fever • nervousness, dizziness, or sleeplessness occur
If pregnant or breastfeeding ask a health professional before use.
Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over | 2 tablets every 4 hours, not to exceed 8 tablets in 24 hours or as directed by a doctor |
Children 6 to under 12 years of age | 1 tablets every 4 hours, not to exceed 4 tablets in 24 hours or as directed by a doctor |
Children 2 under 6 years of age | ½ tablets every 4 hours, not to exceed 2 tablets in 24 hours or as directed by a doctor |
Children under 2 years of age | Consult physician |
Inactive Ingredient
Inactive ingredients: Magnesium Stearate, microcrystalline cellulose, sodium starch glycolate
Storage And Handling
Other information
|
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing |
Other
New Formulation
Contains the same active ingredients as Despec® DM Tablets*
• ANTITUSSIVE • EXPECTORANT • NASAL DECONGESTANT
Manufactured in the USA for Kramer Novis. San Juan, PR 00917. www.kramernovis.com / (787) 767-2072
* Despec® DM Tablets is a registered trademark of International Ethical Laboratories. This product is not manufactured, distributed or marketed by International Ethical Laboratories.
* Please review the disclaimer below.
