Your browser does not support JavaScript! DOCQLACE (DOCUSATE SODIUM) CAPSULE [QUALITEST PHARMACEUTICALS]
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RxNorm Names

DOCQLACE (docusate sodium) capsule
[Qualitest Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

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

Warnings

Do not use 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 lasts over 2 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.  
  • you need to use a laxative for more than 1 week

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.

Directions

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 

Other information

  • 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.

Inactive ingredients

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

This is an image of the label for DocQLace 100 count softgels. 

DOCQLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0603-0150
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
WATER 
SORBITOL 
Product Characteristics
ColorRED (Reddish) Scoreno score
ShapeCAPSULESize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0150-21100 in 1 BOTTLE, PLASTIC
2NDC:0603-0150-321000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33408/01/2011
Labeler - Qualitest Pharmaceuticals (011103059)

Revised: 10/2012
 
Qualitest Pharmaceuticals

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