SENNOSIDES AND DOCUSATE SODIUM- sennosides and docusate sodium tablet 
McKesson Packaging Services a business unit of McKesson Corporation

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

Docusate Sodium 50mg

Sennosides 8.6 mg

Purpose

Docusate Sodium...............Stool Softener

Sennosides.........................Stimulant Laxative

Keep Out of Reach of Children

Uses

Warnings

Do Not Use

  • this product if you are presently 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
  • a sudden change in bowel movements that persists 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

AgeStarting DoseMaximum Dose
Adults and children 12 years of age and over2 tablets once a day4 tablets twice a day
Children 6 to under 12 years1 tablet once a day2 tablets twice a day
Children 2 to under 6 years1/2 tablet once a day1 tablets twice a day
Children under 2 yearsask a doctorask a doctor

Other Information

  • each tablet contains calcium 20mg, sodium 6mg (LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Package/Label Principal Display Panel

Package/Label Principal Display Panel

SENNOSIDES AND DOCUSATE SODIUM 
sennosides and docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-432(NDC:49483-081)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL081
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63739-432-1010 in 1 BOX, UNIT-DOSE11/10/200707/31/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63739-432-0125 in 1 BOX, UNIT-DOSE11/10/200707/31/2021
230 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63739-432-0425 in 1 BOX11/10/200705/31/2013
330 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:63739-432-0230 in 1 BOX07/28/2021
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/11/2007
Labeler - McKesson Packaging Services a business unit of McKesson Corporation (140529962)
Establishment
NameAddressID/FEIBusiness Operations
Legacy Pharmaceutical Packaging, LLC143213275repack(63739-432) , relabel(63739-432)

Revised: 7/2021
Document Id: c8363f13-2759-3987-e053-2a95a90a0a02
Set id: 4258fc68-ac29-491c-b7bc-ed5d35b23107
Version: 3
Effective Time: 20210728
 
McKesson Packaging Services a business unit of McKesson Corporation