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DocQLace

Qualitest Pharmaceuticals

DocQLace


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Docusate sodium 100 mg

Stool softener

  • relieves occasional constipation (irregularity)  
  • generally produces bowel movement in 12 to 72 hours

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

  • stomach pain  
  • nausea  
  • vomiting  
  • noticed a sudden change in bowel habits that lasts over 2 weeks
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.  
  • you need to use a laxative for more than 1 week

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

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

doses may be taken as a single daily dose or in divided doses

adults and children 12 years and over  take 1-3 softgels daily 
children 2 to under 12 years of age  take 1 softgel daily 
children under 2 years  ask a doctor 
  • each softgel contains: sodium 5 mg VERY LOW SODIUM  
  • store at 15°-30°C (59°-86°F)  
  • keep tightly closed

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

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special

Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811

R0  07/2011
015021CPR

PRINCIPAL DISPLAY PANEL

DocQLace 

DocQLace

docusate sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0603-0150
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
polyethylene glycol 400
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
RED (Reddish) 12 mm SCU1 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0603-0150-21 100 in 1 BOTTLE, PLASTIC
2 NDC:0603-0150-32 1000 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2011-08-01


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Be sure to consult your doctor before taking any medication!
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