DocQLace

Drug Labeling and Warnings

Drug Details [pdf]

DOCQLACE- docusate sodium capsule 
Preferred Pharmaceuticals, Inc.

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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DocQLace

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

Repackaged by Preferred Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL

DocQLace 

DOCQLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-0173(NDC: 0603-0150)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorRED (Reddish) Scoreno score
ShapeCAPSULESize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-0173-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/12/201408/28/2019
2NDC: 68788-0173-660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/12/201408/28/2019
3NDC: 68788-0173-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/12/201408/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/12/201408/28/2019
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022REPACK(68788-0173)

Revised: 8/2019
Document Id: 52d6fffc-4c24-4985-92d9-5b0faee3c7b6
Set id: 55038df8-077c-416c-ba5e-aa7fad9f390b
Version: 3
Effective Time: 20190828
 
Preferred Pharmaceuticals, Inc.