DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48433-101(NDC:54629-601)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Inactive Ingredients
Ingredient Name	Strength
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	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	NV12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48433-101-01	100 in 1 BOX, UNIT-DOSE; 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 - Safecor Health, LLC (828269675)

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