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Desgen DM by KRAMER NOVIS

Medically reviewed on October 2, 2017

Dosage form: syrup
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg in 5mL, GUAIFENESIN 100mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 5mL
Labeler: KRAMER NOVIS
NDC Code: 52083-645

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.

DRUG FACTS

Active Ingredients/5 ml: Guaifenesin 100 mg, dextromethorphan hydrobromide 15 mg, phenylephrine hydrochloride 5 mg

Nasal decongestant, Expectorant, antitussive (anti cough)

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

WarningsDo 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.
• 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.
Ask a doctor before use if you have
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


Keep this and all medicines out of the reach of children

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product

Inactives: Citric Acid, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl
Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sucralose.

MM1

do not take more than 4 doses in any 24 hour period,


Adults and children 12 years of age and older-Take 1 teaspoons (5 ml) every 6 hours as needed,
Children 6-12 years, Take 1/2 teaspoon (2.5 ml) every 6 hours as needed,

Children 2-6 years, Take 1/4 teaspoon (1.25 ml) every 6 hours as needed,

Children under 2 years, consult a physician

DESGEN DM 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-645
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CITRIC ACID MONOHYDRATE 
SODIUM CITRATE 
METHYLPARABEN 
PROPYLPARABEN 
GLYCERIN 
PROPYLENE GLYCOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (SWEET GRAPE) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52083-645-16480 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/02/2013
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(52083-645)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack(52083-645)

 
KRAMER NOVIS

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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