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Q Tussin DM by Qualitest Pharmaceuticals

Dosage form: syrup
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0855

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.

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
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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
  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age

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
  • store at 15° to 30°C (59° to 86°F)
  • dosage cup provided

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

PRINCIPAL DISPLAY PANEL
Q TUSSIN DM 
dextromethorphan hbr and guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0855
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
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
DEXTROSE 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
Product Characteristics
ColorRED (clear, red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0855-541 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
2NDC:0603-0855-561 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
2237 mL in 1 BOTTLE, PLASTIC
3NDC:0603-0855-58473 mL in 1 BOTTLE, PLASTIC
4NDC:0603-0855-81237 mL in 1 BOTTLE, PLASTIC
5NDC:0603-0855-94118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/01/1995
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0855)

Revised: 01/2013
 
Qualitest Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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