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Stool Softener plus Laxative by QUALITY CHOICE (Chain Drug Marketing Association)

Dosage form: tablet
Ingredients: DOCUSATE SODIUM 50mg, SENNOSIDES 8.6mg
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
NDC Code: 63868-137

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

Laxative

Purpose

Stool softener

laxative

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

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 breastfeeding,

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

 age

 starting dosage maximum dosage
 adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day
 children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
 children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
 children under 2 years ask a doctor ask a doctor

Other information
  • each tablet contains: calcium 20 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 25ºC (77º); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate, stearic acid, talc* and 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 Senokot-S®

Stool Softener plus laxative

Stool Softener • Laxative

Docusate Sodium, 50 mg/ Sennosides, 8.6 mg
Provides Gentle Relief of: Occasional Constipation

Tablets

†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by C.D.M.A., Inc©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Product Label

Quality Choice Stool Softener Orange Tablets

STOOL SOFTENER PLUS LAXATIVE 
docusate sodium, sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-137
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 
D&C YELLOW NO. 10 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
SILICON DIOXIDE 
SODIUM BENZOATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL081;0805;AV;S35
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-137-601 BOTTLE in 1 BOX
160 TABLET in 1 BOTTLE
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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Medically reviewed on Dec 14, 2018

Further information

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

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