Senna and Docusate Sodium Film Coated Red Tablets 8.6 mg/ 50 mg Laxative

Manufacturer: Sunrise Pharmaceutical Inc
Effective date: 2013-08-02
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 22:36:24

Label at a glance#

ProductSenna and Docusate Sodium

Active ingredientDOCUSATE SODIUM, SENNOSIDES

Label structure11 sections

Indications and uses

For temporary relief of occasional constipation and irregularity. This product generally produces bowel movement in 6 to 12 hours.

Dosage and administration

Drink with a full glass of water with each dose Adults and children 12 years and over take 2 - 4 tablets daily Children 6 to under 12 years take 1 - 2 tablets daily Children 2 to under 6 years take up to 1 tablet daily Children under 2 years of age Ask a doctor OTHER INFORMATION Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM. Do not use if the imprinted safety seal under cap is missing or damaged...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 mg, Sennoside 8.6 mg.

OTC - PURPOSE

OTC - PURPOSE SECTION

Stimulant laxative.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For temporary relief of occasional constipation and irregularity.

This product generally produces bowel movement in 6 to 12 hours.

WARNINGS

WARNINGS SECTION

Do not use:

laxative products for longer than 1 week unless told to do so by a doctor.

if you are presently taking mineral oil, unless told to do so by a doctor

OTC - ASK DOCTOR

OTC - ASK DOCTOR SECTION

Before use if you have:

Stomach pain, nausea or vomiting

Noticed a sudden change in bowel habits that lasts over 2 weeks.

OTC - STOP USE

OTC - STOP USE SECTION

If you have rectal bleeding or fail to have bowel movement after use of a laxative. This could be a serious condition.

OTC - PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - 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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Drink with a full glass of water with each dose

Adults and children 12 years and over	take 2 - 4 tablets daily
Children 6 to under 12 years	take 1 - 2 tablets daily
Children 2 to under 6 years	take up to 1 tablet daily
Children under 2 years of age	Ask a doctor

OTHER INFORMATION

Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM.

Do not use if the imprinted safety seal under cap is missing or damaged.

Store at at 25°C (77°F); excursions permitted between 15(-30(C (59(-86(F)

Keep tightly closed.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, dicalcium phosphate, ethanol, FD&C blue #2, FD&C red #40, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
998740	sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet	PSN	5
998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD	5
998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY	5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11534-134-05	2020-01-31	C162847	48780-1	9d75b9d1-1a7f-f424-e053-dadaa90a57ce	Senna and Docusate Sodium Film Coated Red Tablets 8.6 mg/ 50 mg Laxative
11534-134-60	2020-01-31	C162847	48780-1	9d75b9d1-1a7f-f424-e053-dadaa90a57ce	Senna and Docusate Sodium Film Coated Red Tablets 8.6 mg/ 50 mg Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11534-134-05	Senna and Docusate Sodium	57603 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	TABLET, FILM COATED	57603		5
11534-134-60	Senna and Docusate Sodium	60 in 1 BOTTLE	TABLET, FILM COATED	60		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11534-134	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5	Legacy NDC, 2 package rows	20130802_68d0fe5d-5de2-4853-bf8b-0042f14e8757.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	5
SENNOSIDES	ACTIVE INGREDIENT	3FYP5M0IJX	5
DOCUSATE	ACTIVE MOIETY	M7P27195AG	5
SENNOSIDES	ACTIVE MOIETY	3FYP5M0IJX	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	5
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	5
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	5
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	5

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Senna and Docusate Sodium
DOCUSATE SODIUM
DOCUSATE
SENNOSIDES
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SILICON DIOXIDE
ALCOHOL
FD&C BLUE NO. 2
FD&C RED NO. 40
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POLYETHYLENE GLYCOLS
STARCH, CORN
SODIUM BENZOATE
STEARIC ACID
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11534-134	11534-134-60, 11534-134-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
SENNOSIDES	3FYP5M0IJX	ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
ALCOHOL	3K9958V90M	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MINERAL OIL	T5L8T28FGP	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 · 390 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSE 2208 (100 MPA.S)	HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	POWDER, FOR SUSPENSION / ORAL		250 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	258.45 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET, FILM COATED / ORAL		953 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SHAMPOO / TOPICAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, FILM COATED / ORAL		2 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
HYPROMELLOSE 2208 (100 MPA.S)	HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 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
d08a4708-1de9-4bf4-8444-80d8942995b8			68d0fe5d-5de2-4853-bf8b-0042f14e8757	2013-08-02	Warnings	Exact identifier spl id: d08a4708-1de9-4bf4-8444-80d8942995b8 spl set id: 68d0fe5d-5de2-4853-bf8b-0042f14e8757

Reported adverse events (FAERS/openFDA)#

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