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Stool Softener by EQUATE (Walmart Stores, Inc.)

Medically reviewed on December 11, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: EQUATE (Walmart Stores, Inc.)
NDC Code: 49035-115

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.

Stool Softener

Drug Facts

Active ingredients (in each capsule)

Docusate Sodium 100 mg

Purpose

Stool Softener

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a 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 movements that lasts over 2 weeks

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after using 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 of ages and over take 1 to 3 softgels daily
 Children 2 and under 12 years of age take 1 softgel daily
 children under 2 years of age 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

D&C Red #33, FD&C blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink

Questions or comments?

Call toll free 1-888-287-1915

Principal Display Panel

Stool Softener

Docusate Sodium, 100 mg

Compare to Colacel® Stool Softener Active Ingredient*

60 Softgels

NDC  49035-115-22

Distributed by: Wal-Mart Stores, Inc.

Bentonville, AR 72716

*This product is not manufactured or distributed by Purdue Pharma L.P, owner of the registered trademark Colace®.

Principal Display Panel

Stool Softener

Docusate Sodium, 100 mg

Compare to Colacel® Stool Softener Active Ingredient*

140 Softgels

NDC 49035-115-34

Distributed by: Wal-Mart Stores, Inc.
Bentonville, AR 72716

*This product is not manufactured or distributed by Purdue Pharma L.P, owner of the registered trademark Colace®.

Principal Display Panel

Stool Softener

Docusate Sodium, 100 mg

Compare to Colacel® Stool Softener Active Ingredient*

280 Softgels

NDC 49035-115-35

Distributed by: Wal-Mart Stores, Inc.
Bentonville, AR 72716

*This product is not manufactured or distributed by Purdue Pharma L.P, owner of the registered trademark Colace®.

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-115
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
ANHYDROUS CITRIC ACID 
Product Characteristics
Colorred, white (Two-Tone) Scoreno score
ShapeCAPSULE (Oval) Size13mm
FlavorImprint CodePC18
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-115-221 BOTTLE in 1 CARTON
160 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:49035-115-352 BOTTLE in 1 PACKAGE
2140 CAPSULE, LIQUID FILLED in 1 BOTTLE
3NDC:49035-115-34140 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/15/201504/30/2020
Labeler - EQUATE (Walmart Stores, Inc.) (051957769)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287analysis(49035-115), manufacture(49035-115)

 
EQUATE (Walmart Stores, Inc.)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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