QTUSSIN- guaifenesin solution 
REMEDYREPACK INC.

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 0857

OTC - ACTIVE INGREDIENT

Guaifenesin, USP 100 mg

 

OTC - PURPOSE

Expectorant

 

INDICATIONS & USAGE

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

 

WARNINGS



OTC - ASK DOCTOR

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

 

OTC - STOP USE

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.

 

OTC - PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

 

OTC - KEEP OUT OF REACH OF CHILDREN

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

 

DOSAGE & ADMINISTRATION

  • 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

 

SPL UNCLASSIFIED

  • each tsp contains: sodium 2 mg
  • 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 INGREDIENT

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

 

SPL UNCLASSIFIED

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 5/09 R7
8273611  0857

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: QTussin


GENERIC: Guaifenesin


DOSAGE: SOLUTION


ADMINSTRATION: ORAL


NDC: 52125-871-45


ACTIVE INGREDIENT(S):

  • GUAIFENESIN 100mg in 5mL


INACTIVE INGREDIENT(S):

  • CARAMEL
  • SACCHARIN SODIUM
  • WATER
  • DEXTROSE
  • FD&C RED NO. 40
  • GLYCERIN
  • SODIUM BENZOATE


COLOR: orange


PACKAGING: 118 mL in 1 BOTTLE, PLASTIC




MM1

MM2

QTUSSIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52125-871(NDC:0603-0857)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARAMEL (UNII: T9D99G2B1R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52125-871-45118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/03/201402/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/03/201402/16/2017
Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2017
 
REMEDYREPACK INC.