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Stool Softener Stimulant laxative

Medically reviewed on December 14, 2017

Dosage form: tablet
Ingredients: DOCUSATE SODIUM 50mg, SENNOSIDES 8.6mg
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
NDC Code: 63868-135

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

Stimulant laxative

Uses
  • for overnight relief from occasional constipation (irregularity)
  • generally produces bowel movement in 6 to12 hours

Warnings

Do not use
  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are now 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 oldertake 2-4 tablets daily 
childrens 6 to under 12 years of age  take1-2 tablets daily
children 2 to under 6 years of agetake 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 25ºC(77ºF), protect from heat, light, and moisture

Inactive ingredients

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

*contains one or more of these ingredients

Questions or comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the Active Ingredients in Peri-Colace®

STOOL SOFTENER Plus Stimulant Laxative

Docusate sodium, 50 mg

Sennosides, 8.6 mg

Effective

Reliable

Comfortable 

TABLETS

†This product is not manufactured or distributed by Purdue Products L.P., Distributor of Peri-Colace®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by C.D.M.A. Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Product Label

Quality Choice Stool Softener Red Tablet

STOOL SOFTENER  STIMULANT LAXATIVE
docusate sodium and sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-135
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
SODIUM BENZOATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
FD&C RED NO. 40 
POLYVINYL ALCOHOL 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL097;0806;AV;S44
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-135-10100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33411/30/2015
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

 
QUALITY CHOICE (Chain Drug Marketing Association)

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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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