Dulcolax

Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Effective date: 2017-12-19
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 01:06:05

Label at a glance#

ProductDulcolax

Active ingredientdocusate sodium

Label structure7 sections

Storage and handling

Other information each liquid gel contains : sodium 6mg store at 20-25°C (68-77°F) protect from excessive humidity do not use this product if the safety seal under the cap is torn or missing

Contacts and useful links#

PhoneLabel contact1-888-285-9159

Websitewww.dulcolax.com

www.DULCOLAX.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

*Active ingredient (in each liquid gel)*	*Purpose*
Docusate sodium 100mg	Stool softener laxative

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Use

for temporary relief of occasional constipation and irregularity
this product generally produces bowel movement in 12 to 72 hours

WARNINGS SECTION

Warnings

Ask a doctor before use if you have

stomach pain, nausea or vomiting
a sudden change in bowel habits that lasts more than 2 weeks

OTC - ASK DOCTOR SECTION

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions take with a glass of water

adults and children 12 years and over	1 to 3 liquid gels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age	1 liquid gel daily
children under 2 years of age	ask a doctor

STORAGE AND HANDLING SECTION

Other information

each liquid gel contains: sodium 6mg
store at 20-25°C (68-77°F)
protect from excessive humidity
do not use this product if the safety seal under the cap is torn or missing

INACTIVE INGREDIENT SECTION

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, isopropyl alcohol, mannitol, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, titanium dioxide, water

Questions? Call toll-free 1-888-285-9159 (English/Spanish) Or visit www.DULCOLAX.com

Dist: Boehringer Ingelheim Consumer Health Care Products Division of Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. Copyright © 2014, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dulcolax^® Stool Softener Carton
NDC: 0597-0016-26

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0597-0016-01	2021-11-08	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-18	2021-11-08	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-26	2021-11-08	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-50	2021-11-08	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-55	2021-11-08	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-56	2021-11-08	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-01	2020-01-31	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-18	2020-01-31	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-26	2020-01-31	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-50	2020-01-31	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-55	2020-01-31	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-56	2020-01-31	C162847	48780-1	9d75b9cf-eb37-f424-e053-dadaa90a57ce	Dulcolax® Stool Softener (docusate sodium USP 100mg)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
docusate sodium	ACTIVE INGREDIENT	F05Q2T2JA0	2
docusate	ACTIVE MOIETY	M7P27195AG	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Dulcolax
Docusate sodium
docusate
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
HYPROMELLOSES
POLYETHYLENE GLYCOLS
PROPYLENE GLYCOL
WATER
TITANIUM DIOXIDE
SORBITOL
SORBITAN
MANNITOL
ISOPROPYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0597-0016	0597-0016-01, 0597-0016-18, 0597-0016-26, 0597-0016-50, 0597-0016-55, 0597-0016-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
docusate sodium	F05Q2T2JA0	ACTIB
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SORBITOL	506T60A25R	IACT
SORBITAN	6O92ICV9RU	IACT
MANNITOL	3OWL53L36A	IACT
ISOPROPYL ALCOHOL	ND2M416302	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 8 · 441 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GELATIN	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL		3391 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / RESPIRATORY (INHALATION)	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		616 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		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
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / INTRAVENOUS		15200 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, DELAYED RELEASE / ORAL	19 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	980.4 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / ORAL	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 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
GELATIN	GELATIN	2G86QN327L	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER / ORAL		4352 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER / ORAL	20 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / SUBLINGUAL		19 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, DELAYED RELEASE / ORAL		639 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS		181 mg	Exact identifier — unii candidate 65 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
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE / ORAL		45 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 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
GELATIN	GELATIN	2G86QN327L	SYRUP / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / BUCCAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GEL / RECTAL		348 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SPRAY / NASAL	41.5 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	ELIXIR / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / ORAL		120 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 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
33f9070e-241e-4795-a3af-7fc0f26fbabe			19a67966-be6c-409b-bbbe-33b0b8b65d65	2021-11-04	Warnings	Exact identifier spl set id: 19a67966-be6c-409b-bbbe-33b0b8b65d65

Reported adverse events (FAERS/openFDA)#

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