LAXATIVE DOCUSATE SODIUM WITH SENNA- docusate sodium and sennosides tablet, coated 
TOPCO ASSOCIATES 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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Laxative Docusate Sodium with Senna

Drug Facts

Active ingredients (in each tablet)Purposes
Docusate sodium 50 mgStool softener
Sennosides 8.6 mgStimulant laxative

Uses

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

adults and children 12 years and overtake 2-4 tablets daily
children 6 to under 12 years of agetake 1-2 tablets daily
children 2 to under 6 years of agetake up to 1 tablet daily
children under 2 yearsask a doctor

Other information

Inactive ingredients

colloidal silicon dioxide, crosscarmellose sodium, dibasic calcium phosphate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Questions?

Call 1-888-423-0139

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

NDC 36800-154-01

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

Stool
Softener
+ Stimulant
Laxative

DOCUSATE SODIUM 50 mg
STOOL SOFTENER

SENNOSIDES 8.6 mg
STIMULANT LAXATIVE

For Relief of
Occasional Constipation

100 TABLETS

actual size

Principal Display Panel - 100 Tablet Bottle Carton
LAXATIVE DOCUSATE SODIUM WITH SENNA 
docusate sodium and sennosides tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-861
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
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
FD&C Blue No. 2--Aluminum Lake (UNII: 4AQJ3LG584)  
FD&C Red NO. 40 (UNII: WZB9127XOA)  
Aluminum Oxide (UNII: LMI26O6933)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code S154
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-861-011 in 1 CARTON05/01/2021
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33405/01/2021
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 1/2023
Document Id: d7adc4f4-6bb6-4078-ab48-07dd8649c4d0
Set id: cf9075d8-e20e-419a-b996-9b12f49f05f2
Version: 2
Effective Time: 20230119
 
TOPCO ASSOCIATES LLC