PRESGEN PEDIATRIC- guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup 
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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PRESGEN PEDIATRIC

Drug Facts

Active Ingredients
(in each 5 ml tsp):

Dextromethorphan HBr, 5 mg

Guaifenesin 75 mg

Phenylephrine HCl, 2.5 mg

Purpose:

Cough suppressant

Expectorant

Nasal Decongestant

Uses:

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.

Temporarily relieves :

• nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) 

• cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

Do not use

• in a child under 2 years of age.

• in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

• heart disease          • high blood pressure

• thyroid disease       • diabetes

• 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 exceed recommended dosage.

Stop use and ask a doctor if

• your child gets 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.

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 6 doses in any 24-hour period

EVERY 4 HOURS ADULTS AND CHILDREN 12 YEARS AND OVER 20 mL (4 tsp)
 CHILDREN 6 YEARS TO UNDER 12 YEARS 10 mL (2 tsp)
 CHILDREN 2 YEARS TO UNDER 6 YEARS 5 mL   (1 tsp)
 CHILDREN UNDER 2 YEARS OF AGE do not use

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 and humidity.

Inactive Ingredients:

 Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and Sucralose

Compare to Tussi-Pres Pediatric®

Dextromethorphan HBr

COUGH SUPPRESSANT

Guaifenesin

EXPECTORANT

Phenylephrine HCl

NASAL DECONGESTANT

SUGAR AND ALCOHOL FREE

SACCHARIN & SORBITOL FREE

DYE FREE

ORANGE FLAVOR

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

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

Packaging

Pres1

PRESGEN PEDIATRIC 
guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-653
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN75 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 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
FlavorORANGE (CITRUS ORANGE) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-653-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/24/2011
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)

Revised: 10/2022
Document Id: 045188e8-2c41-476a-b86f-75cf57bc2101
Set id: 12fb91e5-6059-4b3a-a2de-762aa51a25b7
Version: 5
Effective Time: 20221015
 
KRAMER NOVIS