DocQLace

DOCQLACE- docusate sodium capsule 
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.

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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, sorbitol special

Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811

Rev. 7/10 R3
8082517  0145

PRINCIPAL DISPLAY PANEL

This is an image of a DocQLace label.
This is an image of a DocQLace label.
DOCQLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0145
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 0145
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0145-21100 in 1 BOTTLE, PLASTIC
2NDC:0603-0145-321000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/01/199611/01/2013
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Contract Packaging Resources960203917PACK(0603-0145)
Establishment
NameAddressID/FEIBusiness Operations
Swiss Caps USA, INC033105888ANALYSIS(0603-0145), MANUFACTURE(0603-0145)

Revised: 03/2011
 
Qualitest Pharmaceuticals