DOCUSATE SODIUM- docusate sodium capsule, liquid filled
McKesson Packaging Services Business Unit of McKesson Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

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.

Stool softner laxative

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 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

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

Docusate Sodium UD750 Label

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

Docusate Sodium PC750 Label

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

Docusate Sodium UD100 Label

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

DOCUSATE SODIUM
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63739-089
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63739-089-01	25 in 1 BOX, UNIT-DOSE	12/01/2004	11/30/2010
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:63739-089-03	25 in 1 BOX	12/01/2004	03/31/2012
2		30 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:63739-089-10	10 in 1 BOX, UNIT-DOSE	06/20/2007	01/31/2011
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/01/2004	03/31/2012

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

Revised: 7/2021

Document Id: c74009f2-574c-cbda-e053-2995a90a02d6

Set id: 62c8ffe5-321f-4747-ad38-db2c54a393ae

Version: 2

Effective Time: 20210716

McKesson Packaging Services Business Unit of McKesson Corporation