STOOL SOFTENER- docusate sodium capsule, liquid filled 
P & L Development, LLC

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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Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

 Stool softener laxative

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

  • take only by mouth. 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 6 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

D&C red #33*, D&C yellow #10*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin*, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

readyincase™

Compare to the active ingredient in Colace®†

stool softener

docusate sodium 100 mg

for comfortable relief

  • gentle
  • effective
  • stimulant-free

softgels

†This product is not manufactured of distributed by Purdue Products L.P., owner of the registered trademark Colace®.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Product Labeling

Docusate Sodium 100 mg

Readyincase Stool Softener

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-238
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred, whiteScoreno score
ShapeOVALSize12mm
FlavorImprint Code P10;S78;SCU2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-238-011000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/30/201305/31/2021
2NDC:59726-238-0330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/30/201305/31/2021
3NDC:59726-238-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/30/201305/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/30/201305/31/2021
Labeler - P & L Development, LLC (800014821)

Revised: 6/2021
Document Id: a51ce6d4-bbde-41fc-aac6-2a8bcd8708b6
Set id: cf32cdb3-f882-4380-8d38-5856e787fb42
Version: 5
Effective Time: 20210623
 
P & L Development, LLC