SAFETUSSIN DM - dextromethorphan hydrobromide and guaifenesin liquid 
Kramer Laboratories

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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Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Cough suppressant

Expectorant

In case of overdose, get medical help or contact a Poison Control Center right away

temporarily relieves cough due to minor throat and bronchial irritation  
loosen phlegm (mucus)
helps rid bronchial passages of phlegm (mucus)


take every 4 hours not more than 6 doses in any 24-hour period

adults and children 12 years and over 2 tsp every 4 hours

children under 12 years do not use

Aspartame ,BENZOIC ACID   , CITRIC ACID MONOHYDRATE ,glycerin ,methylparaben ,nautral mint flavor  ,propylene glycol,  propylparaben ,
, purified water 

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.

image description

SAFETUSSIN  DM
dextromethorpan guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55505-111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Aspartame 
BENZOIC ACID 
CITRIC ACID MONOHYDRATE  
glycerin 
methylparaben 
MINT 
propylene glycol 
propylparaben 
WATER  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55505-111-33120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/29/2010
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmecuticals001207208manufacture(55505-111)

Revised: 9/2013
Document Id: cabb6a94-5572-4808-a431-b4e1f4d3d69d
Set id: ac9f25a7-03cc-461b-af3e-8c16b7146a22
Version: 3
Effective Time: 20130919
 
Kramer Laboratories