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Docusate Sodium by Safecor Health, LLC

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Safecor Health, LLC
NDC Code: 48433-317

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, USP
Stool Softener

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener

Keep Out of Reach of Children.

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

Uses
For the relief of occasional constipation.
Helps to prevent dry, hard stools.
This product generally produces a bowel movement within 12 to 72 hours.

Warnings

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 one week unless directed by a doctor.

Ask a doctor before use

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

Stop use and ask a doctor

if you have rectal bleeding or you fail to have a bowel movement after use.

If you are pregnant or breast-feeding,

ask a healthcare professional before use.

Directions

Adults and Children over 12 years of age

Take orally 1 to 2 softgels preferably at bedtime for
2-3 days or until bowel movements are normal, or as directed by a doctor.

Children 6 to 12 years of age

Take orally 1 softgel preferably at bedtime for
2-3 days or until bowel movements are normal, or as directed by a doctor.

Children under 6 years of age

Do not use this product for children under 6 years of age, unless directed by a doctor.

Other Information
Each softgel contains 5 mg of Sodium.
Store at room temperature between 15°C to 30°C (59°F to 86°F).
Do not use if seal on packaging is open or missing.

Rev: 317-00 08/2014

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol

Questions or Comments?

Call 1 (800) 447-1006

Package/Label Principal Display Panel
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-317(NDC:54629-600)
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 GLYCOL 1000 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize12mm
FlavorImprint CodeNV13
Contains    
Packaging
#Item CodePackage Description
1NDC:48433-317-10100 POUCH in 1 BOX, UNIT-DOSE
1NDC:48433-317-011 CAPSULE, LIQUID FILLED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/30/2014
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIOperations
Safecor Health, LLC828269675REPACK(48433-317)
Establishment
NameAddressID/FEIOperations
Safecor Health, LLC078805287REPACK(48433-317)

 
Safecor Health, LLC

← See all Docusate Sodium brands

Medically reviewed on Jun 26, 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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