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 Type HUMAN OTC DRUG Item Code (Source) NDC:55505-111
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Aspartame (UNII: Z0H242BBR1)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
methylparaben (UNII: A2I8C7HI9T)  
MINT (UNII: FV98Z8GITP)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55505-111-33 120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/29/2010
Labeler - Kramer Laboratories (122720675)
Establishment
Name Address ID/FEI Business Operations
Denison Pharmecuticals 001207208 manufacture(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