DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by National Vitamin Company, SWISSCAPS Romania srl. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Sodium 100 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 you are 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 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.
• 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 NV13.

Inactive ingredients

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

Package/Label Principal Display Panel

NDC: 54629-600-01
Life-Line®
DOCUSATE SODIUM, USP
STOOL SOFTENER
100 mg Each
100 Softgels

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

Bottle Label

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54629-600
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
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	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	NV13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54629-600-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000
2	NDC: 54629-600-99	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/01/2000

Labeler - National Vitamin Company (102098324)

Establishment
Name	Address	ID/FEI	Business Operations
National Vitamin Company		102098324	MANUFACTURE(54629-600)

Establishment
Name	Address	ID/FEI	Business Operations
SWISSCAPS Romania srl		565466997	MANUFACTURE(54629-600)