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Stool Softener Docusate Sodium

Medically reviewed on July 12, 2017

Dosage form: capsule, gelatin coated
Ingredients: DOCUSATE SODIUM 100mg
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0585

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 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

*This product is not manufactured or distributed by the owner of the registered trademark Colace®.
Distributed by:

​Magno-Humphries Labs​Tigard, OR 97223 U.S.A.

​Visit our website:

www.magno-humphries.com

*This product is not manufactured or distributed by the owner of the registered trademark Colace®.

Distributed by:
​Magno-Humphries Labs​Tigard, OR 97223 U.S.A.
​Visit our website:
www.magno-humphries.com

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
  • WATER
  • POLYETHYLENE GLYCOL 400
  • GLYCERIN
  • SORBITOL

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN, UNSPECIFIED 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
WATER 
SORBITOL 
Product Characteristics
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint CodeSCU1
Contains    
Packaging
#Item CodePackage Description
1NDC:70518-0585-130 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/29/2017
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK 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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