Docusate sodium capsule, liquid filled

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

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 pregnant or breast-feeding,

ask a healthcare professional before use.

Keep out of reach of children.

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

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.
  • 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) 682-9862

Ingredients and appearance - Product information

Docusate sodium capsule, liquid filled- Docusate sodium

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 54629-601
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, unspecified ( 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

Marketing Information

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

Labeler - National Vitamin Company( 102098324)

Establishment

Name ID/FEI Business Operations
National Vitamin Company 102098324 MANUFACTURE( 54629-601)

Package/label principal display panel

NDC 54629-601-01
Life-Line®
Docusate Sodium, USP
Stool Softener
250 mg Each
100 Softgels

Manufactured and Distributed by
National Vitamin Company
Casa Grande, AZ 85122

Bottle Label