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Sennosides and Docusate Sodium

Medically reviewed on January 4, 2018

Dosage form: tablet
Ingredients: SENNOSIDES 8.6mg, DOCUSATE SODIUM 50mg
Labeler: McKesson Packaging Services a business unit of McKesson Corporation
NDC Code: 63739-432

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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
  • Take preferably at bedtime or as directed by a doctor
  • If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable.
AgeStarting DoseMaximum Dose
Adults and children 12 years of age and older2 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)

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, **tapioca starch, **tartaric acid

** may contain one or more of these ingredients

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
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SODIUM BENZOATE 
STEARIC ACID 
TITANIUM DIOXIDE 
STARCH, TAPIOCA 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize5mm
FlavorImprint CodeTCL;081
Contains    
Packaging
#Item CodePackage Description
1NDC:63739-432-1010 BLISTER PACK in 1 BOX, UNIT-DOSE
110 TABLET in 1 BLISTER PACK
2NDC:63739-432-0125 BLISTER PACK in 1 BOX, UNIT-DOSE
230 TABLET in 1 BLISTER PACK
3NDC:63739-432-0425 BLISTER PACK in 1 BOX
330 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other10/11/2007
Labeler - McKesson Packaging Services a business unit of McKesson Corporation (140529962)
Establishment
NameAddressID/FEIOperations
Time-Cap Labs., Inc.037052099MANUFACTURE(63739-432)
Establishment
NameAddressID/FEIOperations
McKesson Packaging Services a business unit of McKesson Corporation140529962REPACK(63739-432)

 
McKesson Packaging Services a business unit of McKesson Corporation

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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