STOOL SOFTENER

STOOL SOFTENER

Drug Labeling and Warnings

Drug Details

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STOOL SOFTENER- docusate sodium capsule, liquid filled 
CVS PHARMACY, INC.

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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STOOL SOFTENER

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours.

Warnings

Do not use

  • 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.
  • you need to use a stool softener laxative for more than 1 week

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 or in divided doses.

adults and children 12 years and over

     take 1 - 3 softgels daily

children 2 to under 12 years of age

     take 1 softgel daily

children under 2 years

     ask a doctor

Other information

  • each softgel contains: sodium 5 mg
  • VERY LOW SODIUM
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat 

Inactive ingredients

anhydrous citric acid, black ink, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white dispersion G.B

Questions or comments?

Call toll free: 1-855-215-8180

Principal Display Panel

STOOL SOFTENER 

DOCUSATE SODIUM 100mg  10 Softgels

Compare to the active ingredient in COLACE

NDC: 69842-169-48

bottle

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69842-169
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Colorred, white (Two-Tone) Scoreno score
Shapecapsule (Oval) Size13mm
FlavorImprint Code PC18
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69842-169-481 in 1 CARTON02/12/2018
110 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/12/2018
Labeler - CVS PHARMACY, INC. (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(69842-169) , analysis(69842-169)

Revised: 6/2018
 
CVS PHARMACY, INC.


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