DOCUSATE SODIUM AND SENNOSIDES- docusate sodium and sennosides tablet 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385

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

  • For overnight relief from occasional constipation (irregularity)
  • generally produces a bowel movement in 6 to 12 hours.

Warnings
Do not use

  • laxative products for longer than 1 week unless told to do so by a doctor.
  • 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

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, preferably in the evening, or in divided doses.
 adults and children 12 years and over take 2-4 tablets daily
 children 6 to under 12 years of age take 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

  • each tablet contains: calcium 20 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  •  store at 15o - 30o C (59o-86o F), protect from excessive moisture

Inactive Ingredients

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

*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 Peri- colace® active ingredients

Stool Softener and stimulant laxative

Docusate Sodium 50 mg
Sennosides 8.6 mg

A gentle, Predictable Laxative

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

**This product is not manufactured or distributed Purdue Products L.P., owner of the registered trademark Peri- Colace®

Product Label

Docusate Sodium and Sennosides

Stool Softener and Stimulant Laxative

DOCUSATE SODIUM AND SENNOSIDES 
docusate sodium and sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-495
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)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
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)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL97;SS2;S44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24385-495-721 in 1 CARTON07/09/201012/31/2018
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:24385-495-781 in 1 CARTON07/09/201012/31/2018
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/09/201012/31/2018
Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 (007914906)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: e04e157f-6c21-4e61-bd54-08c3bbef3cb0
Set id: aba478d6-8f83-472f-9f72-31a3d7c004a2
Version: 3
Effective Time: 20181212
 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385