Search by Drug Name or NDC

NDC 52083-0653-16 PRESGEN PEDIATRIC 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL Details

PRESGEN PEDIATRIC 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL

PRESGEN PEDIATRIC is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by KRAMER NOVIS. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 52083-0653-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 52083-0653-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 52083-0653-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	52083-0653
Product ID	52083-653_045188e8-2c41-476a-b86f-75cf57bc2101
Associated GPIs	43997303100907
GCN Sequence Number	058870
GCN Sequence Number Description	guaifen/dextromethorphan/PE LIQUID 75-5-2.5/5 ORAL
HIC3	B4R
HIC3 Description	NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT
GCN	24395
HICL Sequence Number	000216
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE
Brand/Generic	Brand
Proprietary Name	PRESGEN PEDIATRIC
Proprietary Name Suffix	n/a
Non-Proprietary Name	GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SYRUP
Route	ORAL
Active Ingredient Strength	5; 75; 2.5
Active Ingredient Units	mg/5mL; mg/5mL; mg/5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	KRAMER NOVIS
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52083-0653-16 (52083065316)

Pricing Information	N/A
NDC Package Code	52083-653-16
Billing NDC	52083065316
Package	480 mL in 1 BOTTLE (52083-653-16)
Marketing Start Date	2011-03-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 12fb91e5-6059-4b3a-a2de-762aa51a25b7 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

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