PECGEN DMX- dextromethorphan hbr, guaifenesin solution 
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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PECGEN® DMX

Drug Facts

Active Ingredients (in each 5 mL tsp)

Dextromethorphan HBr, 10 mg

Guaifenesin, 187 mg

Purposes

Antitussive

Expectorant

Uses

• suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive.

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
• 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
• 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

Take every 4 hours, or as directed by a doctor.

Direc

Inactive ingredients

Citric acid, flavors, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Other information

• Store at controlled room temperature 15°-30°C (59°-86°F).
• Avoid excessive heat or humidity.
Tamper Evident Feature: Do not use if inner seal is torn, broken or missing.

Questions or comments?

Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072. San Juan, PR 00917
www.kramernovis.com

Contains the same active ingredients as Trispec® DMX*

Sugar, Alcohol, Dye and Gluten FREE

CHERRY RASPBERRY FLAVOR

Manufactured in the USA for Kramer Novis

*Trispec® DMX is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.

Packaging

Pecgen-1

PECGEN DMX 
dextromethorphan hbr, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-630
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN187 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY, RASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-630-16474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2015
Labeler - KRAMER NOVIS (090158395)

Revised: 9/2019
Document Id: 39b9140f-3d5f-47e8-87db-3985a66681c8
Set id: a627824c-5e3d-4672-a047-6c801b50b432
Version: 4
Effective Time: 20190916
 
KRAMER NOVIS