PRESGEN PEDIATRIC- guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup

PRESGEN PEDIATRIC by

Drug Labeling and Warnings

PRESGEN PEDIATRIC by is a Otc medication manufactured, distributed, or labeled by KRAMER NOVIS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PRESGEN PEDIATRIC 
guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-653
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	75 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	ORANGE (CITRUS ORANGE)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-653-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/24/2011

Labeler - KRAMER NOVIS (090158395)

Registrant - KRAMER NOVIS (090158395)