SENNA S- 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.

----------

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours

Warnings

Do not use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week, unless directed by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues 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

  • take preferably at bedtime or as directed by a doctor
 age starting dosage maximum dosage
 adults and children 12 years of age or older2 tablets
once a day		4 tablets
twice a day
 children 6 to under 12 years1 tablet
once a day		2 tablets
twice a day
 children 2 to under 6 years1/2 tablet
once a day		1 tablet
twice a day
 children under 2 years ask a doctor ask a doctor

Other information

  • each tablet contains: sodium 6 mg/tablet LOW SODIUM
  • each tablet contains: calcium 20 mg/tablet
  • store at 15º-30ºF (59º-86ºF) in well closed containers
  • do not use if imprinted safety seal under cap is broken or missing
  • **This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, silicon dioxide, sodium benzoate, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

**Compare to the Active ingredients in Senokot-S® 

SENNA-S

Docusate Sodium 50 mg

Sennosides 8.6 mg

Stool Softener with laxative

TABLETS

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PL Developments

200 Hicks Street, Westbury, NY  11590

Product Label

Docusate sodium 50 mg, Sennosides 8.6 mg

PL Developments Senna S Tablet

SENNA S 
docusate sodium and sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-160
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL081;SS1;S35
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-160-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/201212/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33405/15/201212/31/2019
Labeler - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: 4d1468e6-2315-4618-af00-7942fd0d0324
Set id: 012152c1-08d5-459f-bb02-86206833988a
Version: 2
Effective Time: 20181221
 
P & L Development, LLC