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PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 187mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 5mL
Labeler: Kramer Novis
NDC Code: 52083-628

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

PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant

Active ingredients (in each 5 mL teaspoonful)

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 187 mg
Pseudoephedrine HCl, USP 30 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation occuring with a cold or inhaled irritants
  • helps loosen phlegm (mucus) 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
  • dif´Čüculty in urination due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a 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
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are acompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be a sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

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

EVERY 4 HOURS

 Adults and children 12 years of age and older:

10 mL (2 tsp.)

 Children 6 to under 12 years of age:

5 mL (1 tsp.)

 Children 2 to under 6 years of age:

2.5 mL (½ tsp)

 Children under 2 years of age:

Consult physician

Other information
  • Tamper evident: Do not use this product if breakaway band on cap is broken or missing.
  • Store at room temperature 15°C-30°C (59°F-86°F)
  • Avoid excessive heat or humidity.
  • Each teaspoon (5 mL) contains: Sodium 16 mg

Inactive ingredients

Citric acid, Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol.

PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant

PECGEN PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR 
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-628
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN187 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52083-628-16474 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/08/2014
Labeler - Kramer Novis (090158395)

Revised: 08/2014
 
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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