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QTussin by Qualitest Pharmaceuticals

Dosage form: solution
Ingredients: GUAIFENESIN 100mg in 5mL
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0857

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 Chest Congestion

Active ingredient (in each 5 mL = 1 tsp)

Guaifenesin, USP 100 mg




helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive


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.

  • use an accurate measuring device to administer this medication 
  • 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 - 4 teaspoons
every 4 hours 

children under
12 years 

do not use

Other information
  • each tsp contains: sodium 2 mg
  • store at 15° to 30°C (59° to 86°F)

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

Inactive ingredients

caramel color, FD&C red #40, flavor, glycerin, liquid glucose, purified water, saccharin sodium, sodium benzoate

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 1/15 R9
8073614  0857

guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0857
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
Product Characteristics
ColorORANGE (clear, reddish-orange) Score    
FlavorImprint Code
#Item CodePackage Description
1NDC:0603-0857-541 BOTTLE, PLASTIC in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
2NDC:0603-0857-561 BOTTLE, PLASTIC in 1 CARTON
2237 mL in 1 BOTTLE, PLASTIC
3NDC:0603-0857-58473 mL in 1 BOTTLE, PLASTIC
4NDC:0603-0857-81237 mL in 1 BOTTLE, PLASTIC
5NDC:0603-0857-94118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/199707/20/2018
Labeler - Qualitest Pharmaceuticals (011103059)
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0857)

Revised: 10/2016
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.