Q TUSSIN DM- dextromethorphan hbr and guaifenesin syrup 
Rebel Distributors Corp

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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Q-Tussin DM 0855

Active ingredients (in each 5 mL = 1 tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

Uses

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

Stop use and ask a doctor if 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

age (yr) 

dose (tsp) 

adults and children
12 years and over 

2 teaspoons
every 4 hours 

children under
12 years 

do not use

Other information

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, liquid glucose, purified water, saccharin sodium, sodium benzoate

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 7/09 R4
8281171  0855

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

Q-Tussin DM 10mg/100mg

Q TUSSIN DM 
dextromethorphan hbr and guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-737(NDC:0603-0855)
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) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorRED (clear, red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-737-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/1995
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 2/2011
Document Id: a70f8ee5-e9c7-41fa-b45d-69e32cd33cf8
Set id: a70f8ee5-e9c7-41fa-b45d-69e32cd33cf8
Version: 1
Effective Time: 20110209
 
Rebel Distributors Corp