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DOCUSATE SODIUM by DIRECT RX

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: DIRECT RX
NDC Code: 61919-459

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.

DOCUSATE SODIUM

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

OTC - PURPOSE SECTION

Stool softener

INDICATIONS & USAGE SECTION
  • for prevention of dry, hard stools
  • for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

WARNINGS SECTION

Do not use

  • if you are currently taking mineral oil, unless directed by a doctor 
  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor 

Ask a doctor before use if

if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

 adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime
 children 6-12 years of age take 1 softgel at bedtime
 children under 6 years ask a doctor

Other information

  • each softgel contains: sodium 6 mg
  • store between 15º-30ºC (59º-86ºF)

Questions or comments?

1-800-645-2158

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN COLACE®*

NON-HABIT FORMING

Stool Softener Laxative

Docusate Sodium USP, 100 mg

SOFTGEL CAPSULES

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

*Rugby Laboratories is not affiliated with the owner of the trademark Colace®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-459(NDC:0536-3756)
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 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColororangeScoreno score
ShapeOVALSize13mm
FlavorImprint CodeP51
Contains    
Packaging
#Item CodePackage Description
1NDC:61919-459-71100 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:61919-459-3030 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2014
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIOperations
DIRECT RX079254320relabel(61919-459)

 
DIRECT RX

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Medically reviewed on May 14, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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