Label: DOCQLACE - docusate sodium syrup 

  • NDC Code(s): 0603-0747-58
  • Packager: Qualitest Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

    Close
  • PURPOSE

    Purpose: Stool Softener

    Close
  • Uses

    • for gentle, reliable relief from occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours
    Close
  • Warnings

    Do not use
    • laxative products for longer than 1 week unless told to do so by a doctor
    • if you are presently taking mineral oil unless told to do so by a doctor
    Ask a doctor before use if you have
    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that last over two weeks
    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.
    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
    Close
  • Directions

    • take as directed by a doctor
    • doses must be given in a 6 to 8 oz glass of milk or fruit juice, to prevent throat irritation
    • take only by mouth. Dose may be taken as a single daily dose or in divided doses.
    • dosage should be adjusted to individual response
    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

    • Store at room temperature 20° -25°C.
    • Protect from freezing and excessive heat
    You may report serious side effects to:
    130 Vintage Drive, Huntsville, AL 35811

    Close
  • 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.

    Close
  • QUESTIONS

    Manufactured for:

    Qualitest Pharmaceuticals
    Huntsville, AL 35811 USA

    Close
  • INGREDIENTS AND APPEARANCE
    DOCQLACE 
    docusate sodium syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0603-0747
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Docusate sodium (Docusate) Docusate sodium 20 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    D&C red no. 33  
    methylparaben  
    propylene glycol  
    propylparaben  
    sodium citrate  
    water  
    sodium benzoate  
    sucrose  
    FD&C red no. 40  
    alcohol  
    glycerin  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor PEPPERMINT Imprint Code
    Contains     
    Packaging
    # 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)
    Close