DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by McKesson Packaging Services Business Unit of McKesson Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Each softgel contains:
Docusate Sodium, 50% w/w in polyethylene glycol 400 (provides 100 mg Docusate Sodium)

Uses

Temporary relief of occasional constipation. This product generally produces a bowel movement in 12 to 72 hours.

Warnings

Do not use:

If abdominal pain, nausea or vomiting are present.

Ask a doctor before use if:

You have noticed a sudden change in bowel habits that persist over a period of 2 weeks. You are presently taking mineral oil. Stop use and ask a doctor if: Rectal bleeding or failure to have a bowel movement occur after use, which may indicate a serious condition. You need to use a laxative for more than 1 week.

If you are pregnant or breast-feeding:

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

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

Directions

Adults and children 12 years of age and over. Take 1 to 3 softgels daily.

Children 2 to under 12 years. Take 1 softgel daily.

Children under 2 years ask a doctor.

Other Information

Each softgel contains: Sodium, 5mg

STORAGE AND HANDLING

Store at 15°-30°C (59°-86°F). Protect from excessive moisture.

Inactive ingredients

Gelatin, Polyethylene Glycol 400, Sorbitol Special™ (Sorbitol, sorbitol anhydrides, purified water and mannitol), Glycerin, Purified Water, Propylene Glycol, FD&C Red #40, FD&C Yellow #6, Edible white printing ink.

PACKAGE DISPLAY PANEL

ADDITIONAL LABEL TEXT

NDC: 63739-089-01

DOCUSATE SODIUM
100 mg Sofgels™

STOOL SOFTENER

UD 750 Softgels (25X30)

Mfg. By: Banner Pharmacaps® High Point, NC USA 27265

Dist. By: McKesson Packaging Concord, NC 28027

FOR INSTITUTIONAL USE ONLY.
See window at back of box for expiration date and lot number.

LS-089-01-M07-01-A-R1

PACKAGE DISPLAY PANEL

ADDITIONAL LABEL TEXT

NDC: 63739-089-03

DOCUSATE SODIUM
100 mg Sofgels™

STOOL SOFTENER

PC 750 Softgels (25X30)

Mfg. By: Banner Pharmacaps® High Point, NC USA 27265

Dist. By: McKesson Packaging Concord, NC 28027

FOR INSTITUTIONAL USE ONLY.
See window at back of box for expiration date and lot number.

PACKAGE DISPLAY PANEL

ADDITIONAL LABEL TEXT

NDC: 63739-089-10

DOCUSATE SODIUM
100 mg Sofgels™

STOOL SOFTENER

UD 100 Softgels (10x10)

For Directions and Other Warnings:
See accompanying Patient Insert.
Consult a physician before the use of this product.

Mfg. By: Banner Pharmacaps® High Point, NC USA 27265

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63739-089
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
MANNITOL (UNII: 3OWL53L36A)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	ORANGE (Orange/Red translucent)	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	P51
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63739-089-01	25 in 1 BOX, UNIT-DOSE
1		30 in 1 BLISTER PACK
2	NDC: 63739-089-03	25 in 1 BOX
2		30 in 1 BLISTER PACK
3	NDC: 63739-089-10	10 in 1 BOX, UNIT-DOSE
3		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		12/01/2004

Labeler - McKesson Packaging Services Business Unit of McKesson Corporation (140529962)