DOCUSATE SODIUM- docusate sodium capsule 
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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Docusate Sodium 100 mg

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 directed 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

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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 stool softner 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

adults and children 12 years and overtake 1 - 3 softgels once daily or in divded doses
children 2 to under 12 years of age1 softgel once daily
children under 2 yearsask a doctor

Other information

  • each softgel contains: s odium 7 mg
  • store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat

Inactive ingredients

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

Questions or comments? Call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

Repackaged and Distributed By:

Remedy Repack, Inc.

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

DRUG: Docusate Sodium

GENERIC: Docusate Sodium

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-2661-0

NDC: 70518-2661-1

COLOR: red

SHAPE: OVAL

SCORE: No score

SIZE: 13 mm

IMPRINT: SCU1

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DOCUSATE SODIUM 100mg in 1

INACTIVE INGREDIENT(S):

  • WATER
  • SORBITOL
  • POLYETHYLENE GLYCOL 400
  • FD&C RED NO. 40
  • GLYCERIN
  • FD&C YELLOW NO. 6
  • GELATIN

Remedy_Label

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-2661(NDC:69618-044)
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
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize13mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-2661-028 in 1 BLISTER PACK; Type 0: Not a Combination Product03/27/202001/06/2021
2NDC:70518-2661-130 in 1 BLISTER PACK; Type 0: Not a Combination Product04/06/202104/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/27/202004/09/2021
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2023
Document Id: f6c88d87-66a6-2962-e053-6294a90acfbe
Set id: 224a671e-2c97-46fb-81d8-3c2fafe2aaa5
Version: 4
Effective Time: 20230313
 
REMEDYREPACK INC.