Docusate sodium capsule, liquid filled

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 15C to 30C (59F to 86F).
  • 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

Ingredients and appearance - Product information

Docusate sodium capsule, liquid filled- Docusate sodium

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 48433-101
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Docusate sodium ( UNII: F05Q2T2JA0)( Docusate - UNII: M7P27195AG ) 250 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Gelatin ( UNII: 2G86QN327L)
Glycerin ( UNII: PDC6A3C0OX)
Polyethylene glycol 1000 ( UNII: U076Q6Q621)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Color RED Size 20 mm
Shape OVAL Score 1
Imprint Code NV12

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 48433-101-01 100 in 1 BOX, UNIT-DOSE 2000/05/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part334 USA 2000/05/01

Labeler - Safecor Health, LLC( 828269675)

Establishment

Name ID/FEI Business Operations
Safecor Health, LLC 828269675 REPACK( 48433-101)

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