Presgen

Dosage form: syrup
Ingredients: GUAIFENESIN 200mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL
Labeler: Kramer Novis
NDC Code: 52083-632

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 per 5 ml: Guaifenesin 200 mg, Phenylephrine HCL 5 mg, Dextromethorphan HBr 10 mg

COUGH SUPPRESSANT

NASAL DECONGESTANT

EXPECTORANT

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

temporarily relieves these symptoms occurring with cold:

nasal congestion

cough due to minor throat and bronchial irritation

Do Not Use: in a child under 2 years of age

if you are 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, thyroid disease, high blood pressure, diabetes

trouble urinating due to enlargement of the prostate gland

cough that occurs with too much phlegm (mucus)

chronic bronchitis or emphysema

When using this product, do not exceed recommended dosage

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

cough lasts more than 7 days, comes back, or is accompanied by fever,

rash, or persistent headache. These could be signs of a serious condition

adults and children 12 years and over 10mL (2 tsp) every 4 hours

children 6 to under 12 years 5mL (1 tsp) every 4 hours

children 2 to under 6 years 2.5mL (1/2 tsp) every 4 hours

under 2 years do not use

do not take more than 6 doses in any 4 hour period

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

Keep out of reach of children

Inactive Ingredients:

citric acid,red 40,glycerin,methylparaben,potassium sorbate,propylene glycol,propylparaben,purified water,sodium citrate,sucralose

MM1

PRESGEN 
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-632(NDC:62959-100)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
SODIUM CITRATE 
METHYLPARABEN 
PROPYLPARABEN 
SUCRALOSE 
POTASSIUM SORBATE 
Product Characteristics
Colorred (CHERRY RED) Score    
ShapeSize
FlavorCHERRY (SOUR CHERRY) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52083-632-16480 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/28/2011
Labeler - Kramer Novis (090158395)
Registrant - Kramer Novis (090158395)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack

Revised: 03/2011
 
Kramer Novis

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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