Stool Softener Laxative by REMEDYREPACK INC. Drug Facts

Stool Softener Laxative by

Drug Labeling and Warnings

Stool Softener Laxative by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOOL SOFTENER LAXATIVE- docusate sodium capsule 
REMEDYREPACK INC.

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Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

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 last 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 a signs of a serious condition.
  • you need to use a 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 (1-800-222-1222)  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 overtake 1 to 3 softgels daily.
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years ask a doctor

Other information

  • each softgel contains: sodium 5 mg
  • store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

Questions or comments?

 Call 1-800-616-2471

PRINCIPAL DISPLAY PANEL

DRUG: Docusate Sodium

GENERIC: DOCUSATE SODIUM

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-3049-0

NDC: 70518-3049-1

COLOR: orange

SHAPE: OVAL

SCORE: No score

SIZE: 12 mm

IMPRINT: P51

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 7 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DOCUSATE SODIUM 100mg in 1

INACTIVE INGREDIENT(S):

  • FD&C RED NO. 40
  • FD&C YELLOW NO. 6
  • GELATIN
  • SORBITAN
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • PROPYLENE GLYCOL
  • WATER
  • SORBITOL
  • GLYCERIN
  • MEDIUM-CHAIN TRIGLYCERIDES

Remedy_Label

STOOL SOFTENER LAXATIVE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70518-3049(NDC: 0904-6998)
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)  
SORBITAN (UNII: 6O92ICV9RU)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70518-3049-030 in 1 BLISTER PACK; Type 0: Not a Combination Product03/17/202104/13/2024
2NDC: 70518-3049-17 in 1 BLISTER PACK; Type 0: Not a Combination Product06/09/202108/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00703/17/202104/13/2024
Labeler - REMEDYREPACK INC. (829572556)

Revised: 9/2024
Document Id: 22cd44ef-4b09-604d-e063-6394a90a7a0a
Set id: 5ccb4f2a-5548-4b00-8398-dade4530473f
Version: 4
Effective Time: 20240923
 
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