Docusate Sodium

Manufacturer: McKesson Packaging Services Business Unit of McKesson Corporation
Effective date: 2009-12-14
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:54:32

Label at a glance#

ProductDocusate Sodium

Active ingredientDOCUSATE SODIUM

Label structure11 sections

Indications and uses

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

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use:

OTC - DO NOT USE SECTION

If abdominal pain, nausea or vomiting are present.

Ask a doctor before use if:

OTC - ASK DOCTOR/PHARMACIST SECTION

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:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

Each softgel contains: Sodium, 5mg

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL 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

PACKAGE LABEL.PRINCIPAL 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

PACKAGE LABEL.PRINCIPAL 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-089-01	2021-07-16	C162847	48780-1	9d75b9d0-7c72-f424-e053-dadaa90a57ce	Drug Facts
63739-089-03	2021-07-16	C162847	48780-1	9d75b9d0-7c72-f424-e053-dadaa90a57ce	Drug Facts
63739-089-10	2021-07-16	C162847	48780-1	9d75b9d0-7c72-f424-e053-dadaa90a57ce	Drug Facts
63739-089-01	2020-01-31	C162847	48780-1	9d75b9d0-7c72-f424-e053-dadaa90a57ce	Drug Facts
63739-089-03	2020-01-31	C162847	48780-1	9d75b9d0-7c72-f424-e053-dadaa90a57ce	Drug Facts
63739-089-10	2020-01-31	C162847	48780-1	9d75b9d0-7c72-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-089-03	EA - Each	63739-089	09e05717-e1ea-464a-95d9-11d2c24b356f	1	2012-07-24
63739-089-10	EA - Each	63739-089	45ad82f9-f4a1-4187-b3dc-ed4956c27287	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Docusate Sodium
DOCUSATE
POLYETHYLENE GLYCOL 400
SORBITOL
WATER
MANNITOL
GLYCERIN
PROPYLENE GLYCOL
FD&C RED NO. 40
FD&C YELLOW NO. 6

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63739-089	63739-089-01, 63739-089-03, 63739-089-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
MANNITOL	3OWL53L36A	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 363 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GUM, CHEWING / BUCCAL		891 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS		181 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAVENOUS		24186 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	EMULSION / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION, CONCENTRATE / INTRAVENOUS		220 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	DROPS / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION/ DROPS / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / INTRAMUSCULAR	106.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SYRUP / ORAL	4 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SOLUTION / ORAL		3767 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii candidate 34 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL		3391 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / SUBCUTANEOUS		675 mg	Exact identifier — unii candidate 65 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c74009f2-574c-cbda-e053-2995a90a02d6			62c8ffe5-321f-4747-ad38-db2c54a393ae	2021-07-16	Warnings	Exact identifier spl set id: 62c8ffe5-321f-4747-ad38-db2c54a393ae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.