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Docusate Sodium by Safecor Health, LLC

Medically reviewed on June 28, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 250mg
Labeler: Safecor Health, LLC
NDC Code: 48433-101

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

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information
Each softgel contains 13 mg of Sodium.
Keep lid tightly closed.
Store at room temperature between 15°C to 30°C (59°F to 86°F).
Do not use if printed seal under cap is broken or missing.
For identification purposes, each softgel will have an imprint that reads NV12.

Inactive ingredients

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

Questions

Call 1 (800) 447-1006

Package/Label Principal Display Panel

Safecor Health


Docusate Sodium, USP
250 mg Each

NDC 48433-101-01


100 Unit Dose Softgels

Packaged and Distributed by:

Safecor Health, LLC

Columbus, OH 43204

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-101(NDC:54629-601)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM250 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
ShapeOVALSize20mm
FlavorImprint CodeNV12
Contains    
Packaging
#Item CodePackage Description
1NDC:48433-101-01100 CAPSULE, LIQUID FILLED in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/2000
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIOperations
Safecor Health, LLC828269675REPACK(48433-101)

 
Safecor Health, LLC

← See all Docusate Sodium brands

Further information

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

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