PECGEN DMX  - guaifenesin and 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.

----------

DRUG FACTS

Active Ingredients/5 ml: guaifenesin 125 mg dextromethorphan hydrobromide 15 mg

Cough suppressant, expectorant

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

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

Do not:
• use more than the recommended dose
• give this product to a child who has heart disease, high blood pressure, thyroid
disease, or diabetes unless directed by a doctor.
• 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.
• diabetes • heart disease • thyroid disease • high blood pressure • 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.
Ask a doctor before use if you have
When using this product do not use more than directed
Stop use and ask a doctor if
•you get nervous, dizzy, or sleepless
•symptoms do not get better within 7 days or are accompanied by fever
•Coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a
persistent headache. These could be signs of a serious condition.

Keep this and all medicines out of the reach of children

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product

Inactives: Citric Acid, FDC Red 40, Flavor, Glycerin, Methylparaben, propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Sucralose

MM1

PecgenDMX

Directions Adults and Children 12 years of age and over 10 mL (2 tsp)
Children 6 to under 12 years of age 5 mL (1 tsp) E V E RY
6 HOURS
do not take more than 4 doses in any 24-hour period
PECGEN DMX  
guaifenesin,dextromethorphan hydrobromide syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-620
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 125 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (SWEET C HERRY) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52083-620-16 480 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/29/2011
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)
Establishment
Name Address ID/FEI Business Operations
ULTRAtab Laboratories, Inc. 151051757 manufacture(52083-620)
Establishment
Name Address ID/FEI Business Operations
Ultra Seal Corporation 085752004 repack(52083-620)

Revised: 2/2013
Document Id: 6d01b9b3-f258-4843-9a07-9627271cee67
Set id: 1e650c14-dabb-486e-9d12-6ec90ed321aa
Version: 1
Effective Time: 20130204
 
KRAMER NOVIS