STOOL SOFTENER DOCUSATE SODIUM- docusate sodium capsule, gelatin coated 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Stool Softener Docusate Sodium

MHL
NDC 54257-902-06

Stool Softener
Docusate Sodium 100mg

Compare to the active ingredient in Colace ®*

Effective, Gentle
Stimulant Free
For Comfortable Relief

1000 SOFTGELS

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Active ingredient (in each softgel)

Docusate sodium 100mg

Purpose

Stool softener

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12-72 hours

Warnings

​Do not use

  • if you are presently taking mineral oil, unless told by a doctor

​Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

​Stop use and ask a doctor if

  • you have rectal bleeding or you 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 for mroe than 1 week.

​If pregnant or breast-feeding, ​ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center ( ​1-800-222-1222​) right away.

Directions

  • Take only by mouth. This dose may be taken as a single daily dose or in divided doses.
  • ​adults and children over 12 years of age: ​take 1-3 softgels daily or as directed by a doctor
  • ​children 2 to under 12 years of age:​ take 1 softgel daily or as directed by a doctor
  • ​children under 2 years of age: ​ask a doctor

Other information

  • ​each softgel contains: ​sodium 7mg
  • store between 15° to 30°C (59° to 86°F)
  • Protect from moisture

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol.

Questions?

call toll-free ​1-800-935-6737

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Stool Softener Docusate Sodium

GENERIC: DOCUSATE SODIUM

DOSAGE: CAPSULE, GELATIN COATED

ADMINSTRATION: ORAL

NDC: 70518-0585-0

NDC: 70518-0585-1

COLOR: red

SHAPE: OVAL

SCORE: No score

SIZE: 12 mm

IMPRINT: SCU1

PACKAGING: 7 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DOCUSATE SODIUM 100mg in 1

INACTIVE INGREDIENT(S):

  • GELATIN, UNSPECIFIED
  • GLYCERIN
  • POLYETHYLENE GLYCOL 400
  • WATER
  • SORBITOL

MM1

MM2

STOOL SOFTENER DOCUSATE SODIUM 
docusate sodium capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0585(NDC:54257-902)
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
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0585-07 in 1 BLISTER PACK; Type 0: Not a Combination Product06/29/201710/13/2023
2NDC:70518-0585-130 in 1 BLISTER PACK; Type 0: Not a Combination Product06/29/201710/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/29/201710/13/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
 
REMEDYREPACK INC.