DESGEN DM TABS- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride tablet 
KRAMER NOVIS

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DESGEN DM Tabs

Drug Facts

 Active ingredients (in each tablet)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Pseudoephedrine HCl, 30 mg

Purpose

Antitussive

Expectorant

Nasal Decongestant

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 ingredients: Magnesium Stearate, microcrystalline cellulose, sodium starch glycolate

Other information
  • Store at room temperature 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing

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.

Packaging

ds 1

DESGEN DM TABS 
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-648
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code KN648
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-648-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01208/26/2015
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)

Revised: 1/2024
Document Id: f5bc8478-e93d-4d5b-b744-5b0c49843d35
Set id: 74a2937d-12d5-4c0b-b237-074b4d7c30b1
Version: 4
Effective Time: 20240104
 
KRAMER NOVIS