STOOL SOFTENER- docusate sodium capsule, liquid filled 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385

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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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 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 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 6 mg
  • store at controlled room temperature 15o - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®

Inactive Ingredients

D&C Red #33, edible ink, *FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, *purified water, sorbitol special, and titanium dioxide.

*May also contain

Questions or comments?

Call toll free 1-877-753-3935

Principal display panel

*compare to colace® active ingredient

STOOL SOFTENER

Docusate Sodium, 100 mg

safe, gentle & reliable

Product Label

Good Neighbour Pharmacy Stool softener softgels

Docusate Sodium 100 mg

 

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-436
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
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 GLYCOL 1000 (UNII: U076Q6Q621)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize13mm
FlavorImprint Code P10;51A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24385-436-721 in 1 BOX
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:24385-436-78100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/08/201002/29/2016
Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 (007914906)

Revised: 2/2016
Document Id: 6994bd84-dba3-4342-9b12-9cf02953f45a
Set id: ce4e75b4-af27-46bc-9786-2b1ff0fa7acc
Version: 2
Effective Time: 20160226
 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385