STOOL SOFTENER DOCUSATE SODIUM 50 MG- 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 DOCUSATE SODIUM 50mg, Capsule, liquid filled

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 50 mg

Purpose

Stool softener

Uses

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 to 6 softgels daily

Children 2 to under 12 years of age

take 1 to 3 softgels daily

children under 2 years

ask a doctor

Other information

Inactive ingredients

citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei 430206,
China

PRINCIPAL DISPLAY PANEL - 30ct Carton and Bottle Label

STOOL SOFTENER DOCUSATE SODIUM 50 MG 30ct

NDC 69842-072-20

Compare to the active ingredient in Colace® 50 mg

30ct Carton Label

30ct Bottle Label

PRINCIPAL DISPLAY PANEL - 100ct Carton and Bottle Label

STOOL SOFTENER DOCUSATE SODIUM 50 MG 100ct

NDC 69842-072-24

Compare to the active ingredient in Colace® 50 mg

100ct Carton Label

100ct Bottle Label

STOOL SOFTENER DOCUSATE SODIUM 50 MG 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-072
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Colorred (clear) Scoreno score
ShapeCAPSULE (OVAL) Size13mm
FlavorImprint Code PC20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-072-201 in 1 CARTON12/14/2016
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:69842-072-241 in 1 CARTON12/14/2016
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/14/2016
Labeler - CVS PHARMACY, INC. (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287analysis(69842-072) , manufacture(69842-072)

Revised: 11/2019
Document Id: 95861d39-f88d-4c68-aa90-3fc440be8a80
Set id: 3f6c1ef9-e286-416f-b727-7be08bef49fa
Version: 2
Effective Time: 20191121
 
CVS PHARMACY, INC.