STOOL SOFTENER- docusate sodium capsule, liquid filled 
Freds 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.

----------

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

  • for temporary relief of occasional constipation and irregularity 
  • this product generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking mineral oil.

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using a laxative. These could be sign of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health care 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 with a glass of water
 adults and children 12 years of age and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years of age ask a doctor

Other information

  • each softgel contains: sodium 7mg
  • store at 25ºC (77º); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, medium-chain triglycerides*,polyethylene glycol, propylene glycol*, purified water sorbitan,sorbitol

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Stool Softener

Docusate Sodium, 100mg

Gentle Relief

Dependable Relief of Occasional Constipation

SOFTGELS

Compare to the active ingredient in: Dulcolax® Stool Softener†

†This product is not manufactured or distributed by Boehringer Ingelheim Consumer Health Care Products, Division of Boehringer Ingelheim Pharmaceuticals, Inc., and owner of the registered traemark Dulcolax®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN 38118

www.fredsinc.com

Product Label

Docusate sodium 100mg

Freds Stool Softener

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-244
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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)  
SORBITAN (UNII: 6O92ICV9RU)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51;S77;SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-244-251 in 1 BOX04/30/201504/26/2024
125 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 finalpart33404/30/201504/26/2024
Labeler - Freds Inc (005866116)

Revised: 10/2021
Document Id: 4c396dba-4f4d-4abe-b006-b2bbf09689ac
Set id: 0382bb0d-38bb-4b6b-b804-d0e4482081a8
Version: 4
Effective Time: 20211019
 
Freds Inc