DESGEN PEDIATRIC- dextromethorphan hbr, guiafenesin, phenylephrine hcl solution/ drops 
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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Drug Facts

Active Ingredients (in each 1 mL)                    Purpose

Dextromethorphan HBr, 5 mg..............................Antitussive

Guaifenesin, 50 mg..............................................Expectorant

Phenylephrine HCl, 2.5 mg................................Nasal decongestant



Uses


Warnings

Do not use
in 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 a MAOI, ask a doctor or pharmacist before giving this product.


Ask a doctor before use if your child has

When using this product do not exceed recommended dosage

Stop use and ask a doctor if


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 use more than 6 doses in any 24-hour period

Children 2 to under 5 years of age

Children under 2, consult a doctor.


Other information

Tamper Evident Feature: Do not use if cap 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, flavors, glycerin, methyl paraben, polyethylene glycol, propylene glycol, propyl paraben, purified water, sodium citrate, sorbitol and sucralose.

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072

Principal Display Panel

DESGEN

PEDIATRIC DROPS

Contains the same active ingredients as Despec® EDA drops

Antitussive

Expectorant

Nasal Decongestant

Sugar, Alcohol & Dye Free

NET CONTENT: 30 mL (1 Fl. Oz.)

KRAMER-NOVIS

kramer-supress-pe

DESGEN  PEDIATRIC
dextromethorphan hbr, guiafenesin, phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-641
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-641-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/27/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2014
Labeler - Kramer Novis (090158395)

Revised: 9/2019
Document Id: e780b307-299b-45ea-9b56-01faee3cdec0
Set id: 12425c1b-8bdc-446b-83dd-95e05a4d9b8c
Version: 3
Effective Time: 20190916
 
Kramer Novis