Non-Habit Forming Stool Softener

Manufacturer: Aidarex Pharmaceuticals LLC
Effective date: 2012-10-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:33:13

Label at a glance#

ProductNon-Habit Forming Stool Softener

Active ingredientDOCUSATE SODIUM

Label structure9 sections

Indications and uses

Relieves occasional constipation. Generally produces bowel movement within 12 to72 hours.

Dosage and administration

adults and children over 12 years and over: 1 capsule once daily or in divided doses children 6 to under 12 years : 1 capsule once daily children under 6 years: ask a doctor

Storage and handling

store at controlled room temperature 15 - 30 degrees C (59-86 degrees F) Each capsule contains sodium 6mg

Contacts and useful links#

PhoneLabel contact1-800-645-2158

Websitewww.rugbylaboratories.com

www.rugbylaboratories.com

Label contents#

Full prescribing information#

Active Ingredient (in each softgel capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

Relieves occasional constipation.
Generally produces bowel movement within 12 to72 hours.

Warnings - Do not use

WARNINGS SECTION

for longer than one week
if you are taking mineral oil
when abdominal pain, nausea, or vomiting are present

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience rectal bleeding
you fail to have a bowel movement after using this product

These may indicate a serious condition.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years and over:1 capsule once daily or in divided doses
children 6 to under 12 years: 1 capsule once daily
children under 6 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

Each capsule contains sodium 6mg

Inactive Ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158, 9am - 5am ET Monday - Friday

Product Labeling

SPL UNCLASSIFIED SECTION

Rugby Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250mg

*Rugby Laboratories, Inc is not affiliated with the ower of the trademark Colace(r).

Rugby stool softener Laxative is distributed by Rugby Laboratories, Inc.

Mfd for: Rugby Laboratories, Inc
Duluth Georgia 30097
www.rugbylaboratories.com

Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	1
1115005	docusate sodium 100 MG Oral Capsule	SCD	1
1115005	DOSS Sodium 100 MG Oral Capsule	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-039-00	2020-01-31	C162847	48780-1	9d75b9d0-5b6c-f424-e053-dadaa90a57ce	Non-Habit Forming Stool Softener Laxative
33261-039-02	2020-01-31	C162847	48780-1	9d75b9d0-5b6c-f424-e053-dadaa90a57ce	Non-Habit Forming Stool Softener Laxative
33261-039-10	2020-01-31	C162847	48780-1	9d75b9d0-5b6c-f424-e053-dadaa90a57ce	Non-Habit Forming Stool Softener Laxative
33261-039-20	2020-01-31	C162847	48780-1	9d75b9d0-5b6c-f424-e053-dadaa90a57ce	Non-Habit Forming Stool Softener Laxative
33261-039-30	2020-01-31	C162847	48780-1	9d75b9d0-5b6c-f424-e053-dadaa90a57ce	Non-Habit Forming Stool Softener Laxative
33261-039-60	2020-01-31	C162847	48780-1	9d75b9d0-5b6c-f424-e053-dadaa90a57ce	Non-Habit Forming Stool Softener Laxative
33261-039-90	2020-01-31	C162847	48780-1	9d75b9d0-5b6c-f424-e053-dadaa90a57ce	Non-Habit Forming Stool Softener Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-039-00	Non-Habit Forming Stool Softener	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100	1
33261-039-02	Non-Habit Forming Stool Softener	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120	1
33261-039-10	Non-Habit Forming Stool Softener	10 in 1 BOTTLE	CAPSULE, LIQUID FILLED	10	1
33261-039-20	Non-Habit Forming Stool Softener	20 in 1 BOTTLE	CAPSULE, LIQUID FILLED	20	1
33261-039-30	Non-Habit Forming Stool Softener	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30	1
33261-039-60	Non-Habit Forming Stool Softener	60 in 1 BOTTLE	CAPSULE, LIQUID FILLED	60	1
33261-039-90	Non-Habit Forming Stool Softener	90 in 1 BOTTLE	CAPSULE, LIQUID FILLED	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-039	NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 7 package rows	20121007_e6b1263b-a09e-4f4e-bcba-d0f67d6a9e24.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-039-00	EA - Each	33261-039	f1c2abc5-ed3f-4c04-91d3-5de0ea84dd93	1	2015-10-02
33261-039-02	EA - Each	33261-039	de01e6ea-319e-4a3e-aaa7-99fac5c42d0c	1	2015-10-02
33261-039-30	EA - Each	33261-039	f3c2752b-aa4e-4d42-947a-e6cade724f47	1	2015-10-02
33261-039-60	EA - Each	33261-039	f7202589-e26d-48ac-8d55-ac3b1c2cd0a9	1	2015-10-02
33261-039-90	EA - Each	33261-039	d8314623-864d-4f33-bc58-2eac7dc05732	1	2015-10-02
0536-3756-01	EA - Each	0536-3756	8fd965ad-aad1-4339-b7a2-362c0a1f3061	1	2012-07-24
0536-3756-10	EA - Each	0536-3756	3791905f-77b1-4557-9988-9c77fa97f976	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
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	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 · 11 matching rows.

Non-Habit Forming Stool Softener
DOCUSATE SODIUM
DOCUSATE
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
PROPYLENE GLYCOL
WATER
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
33261-039	33261-039-00, 33261-039-02, 33261-039-10, 33261-039-20, 33261-039-30, 33261-039-60, 33261-039-90
0536-3756

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
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	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 6 · 306 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	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 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
GELATIN	GELATIN	2G86QN327L	SYSTEM / TOPICAL		1050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %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
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 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	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, SUSPENSION / INTRAMUSCULAR	1.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED PELLETS / ORAL	65 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SOLUTION / ORAL	34.8 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / RECTAL	0.5 %w/v		Exact identifier — unii candidate 34 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
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 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 / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, CHEWABLE / ORAL		24 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	LOTION / TOPICAL	NA		Exact identifier — unii candidate 34 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
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 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
67a1c308-26ed-4150-8e1e-21c9d07d220f			e6b1263b-a09e-4f4e-bcba-d0f67d6a9e24	2012-10-05	Warnings	Exact identifier spl id: 67a1c308-26ed-4150-8e1e-21c9d07d220f spl set id: e6b1263b-a09e-4f4e-bcba-d0f67d6a9e24

Reported adverse events (FAERS/openFDA)#

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