Your browser does not support JavaScript! PECGEN DMX (GUAIFENESIN,DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]
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PECGEN DMX (guaifenesin,dextromethorphan hydrobromide) syrup
[KRAMER NOVIS]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52083-620
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN125 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
METHYLPARABEN 
PROPYLPARABEN 
PROPYLENE GLYCOL 
SODIUM CITRATE 
SUCRALOSE 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (SWEET C HERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-620-16480 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/29/2011
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(52083-620)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004repack(52083-620)

Revised: 2/2013
 
KRAMER NOVIS

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