DOCQLACE - docusate sodium syrup 
Qualitest Pharmaceuticals

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.


DocQLace Syrup

Active Ingredient (in each 15 mL (1 tablespoonful)) :Docusate sodium 60 mg

Purpose: Stool Softener



Do not use
Ask a doctor before use if you have
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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.


adults and children 12 years of age and older
1 to 6 tablespoonfuls, or as directed by a doctor
children 6 to under 12 years of age
1 to 2 1/2 tablespoonfuls, or as directed by a doctor
children under 6 years
Ask a doctor
Other information

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

Inactive ingredients

alcohol (not more than 1%), citric acid, D&C red no. 33, FD&C red no.40, peppermint flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucrose.

Manufactured for:

Qualitest Pharmaceuticals
Huntsville, AL 35811 USA

Container Label

docusate sodium syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0747
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Docusate sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate sodium 20 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid (UNII: XF417D3PSL)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
sodium citrate (UNII: 1Q73Q2JULR)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sucrose (UNII: C151H8M554)  
FD&C red no. 40 (UNII: WZB9127XOA)  
alcohol (UNII: 3K9958V90M)  
glycerin (UNII: PDC6A3C0OX)  
Product Characteristics
Color      Score     
Shape Size
Flavor PEPPERMINT Imprint Code
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0603-0747-58 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 10/05/1990
Labeler - Qualitest Pharmaceuticals (011103059)

Revised: 12/2012
Document Id: 95206544-6a53-4ac2-b2e4-b33fb7782752
Set id: 3bbec27b-13a0-4bb6-bc1a-b89679cc9869
Version: 9
Effective Time: 20121228
Qualitest Pharmaceuticals