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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.

PECGEN® PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR

Drug Facts

Active Ingredients (in each 5 mL tsp)

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 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 • 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 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.

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

Keep out of reach of children. In case of accidental 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

Adults and children 12 years of age and older

2 teaspoonfuls (10 mL) every 4 hours, not to exceed 8 teaspoonfuls in 24 hours or as directed by a doctor

Children 6 to under 12 years of age

1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by a doctor

Children 2 to under
6 years of age

Consult a doctor

Other information

• Store at controlled room temperature 15°C-30°C (59°F-86°F)

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

Inactive ingredients

Citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Contains the same active ingredients as Tri‚Äčspec® PSE

• SUGAR FREE • ALCOHOL FREE

• DYE FREE • GLUTEN FREE

GRAPE FLAVOR

Manufactured in the USA for Kramer Novis. San Juan, PR 00917.

Tel: (787) 767-2072  www.kramernovis.com

* Trispec® PSE is a Registered Trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.

Packaging

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 
METHYLPARABEN 
AMMONIUM GLYCYRRHIZATE 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SORBITOL 
SUCRALOSE 
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)

 
Kramer Novis

Medically reviewed on Dec 11, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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