DESGEN DM- dextromethorphan hbr ,guaifenesin ,phenylephrine hcl solution 
Kramer Novis

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DESGEN DM

Active ingredients (in each 5 mL tsp)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

Phenylephrine HCL, 5mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

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

Uses

• Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make   coughs more productive
• temporarily relieves nasal congestion due to a cold

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
• diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product do not use more than directed

Stop use and ask a doctor if
• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Directions

Do not take more than 6 doses in any 24-hour period


Every 4 hours
Adult and Children 12 years of age and over           10 mL (2 tsp)
Children 6 to under 12 years of age                         5 mL (1 tsp)
Children under 6 years of age                                Consult physician

Inactive ingredients

Citric Acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.

Other Information

• Tamper evident feature: Do not use if inner seal is torn, broken or missing.
• Store at controlled room temperature 15-30°C (59-86°F).
• Avoid excessive heat or humidity

Manufactured in the USA for Kramer Novis, San Juan, PR 00917, Tel (787) 767-2072 / www.kramernovis.com

Packaging

image description

DESGEN DM 
dextromethorphan hbr ,guaifenesin ,phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-646
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorgrapeImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-646-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/18/2014
Labeler - Kramer Novis (090158395)
Registrant - Kramer Novis (090158395)

Revised: 11/2019
Document Id: 57de1640-53c1-427d-9b5d-1088cf309a76
Set id: 6ab47174-e1fd-47ce-8788-06b7cdad5218
Version: 2
Effective Time: 20191113
 
Kramer Novis