STOOL SOFTENER WITH STIMULANT LAXATIVE- docusate sodium and sennosides tablet 
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 ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are now 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 a period of 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 may indicate a serious condition.

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

adults and children 12 years and oldertake 2-4 tablets daily 
children 6 to under 12 years of agetake 1-2 tablets daily 
children 2 to under 6 years of age take up to 1 tablet daily 
children under 2 ask a doctor 

Other information

Inactive ingredients

carnauba wax*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, silcon dioxide, sodium benzoate*, stearic acid, talc*, 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

stool softener + stimulant laxative

docusate sodium 50 mg

(stool softener )

sennosides 8.6 mg

(stimulant laxative)

tablets

†Compare to the active ingredients in Colace® 2-IN-1

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

†This product is not manufactured or distributed by Avrio Health LP., distributor of Colace® 2-IN-1

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

Product Label

Docusate Sodium 50 mg, Sennosides 8.6 mg

WELLNESS BASICS Stool Softener

STOOL SOFTENER WITH STIMULANT LAXATIVE 
docusate sodium and sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-829
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL097;PSD21;S44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-829-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/201812/31/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/31/201812/31/2025
Labeler - P & L Development, LLC (800014821)

Revised: 4/2023
Document Id: bc4ceb13-ec8f-4d49-b1bc-c4f5f07d2243
Set id: d8a90181-f59f-45bc-b691-3645604af2e6
Version: 3
Effective Time: 20230420
 
P & L Development, LLC