Senna and Docusate Sodium

Manufacturer: Sunrise Pharmaceutical Inc
Effective date: 2013-08-07
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:36:27

Label at a glance#

ProductSenna and Docusate Sodium

Active ingredientDOCUSATE SODIUM, SENNOSIDES

Label structure12 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a bowel movement within 6 to 12 hours

Dosage and administration

Take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age or older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years ½ tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE

OTC - PURPOSE SECTION

Stool softener and Stimulant laxative

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity)
generally produces a bowel movement within 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 A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

Stomach pain
Nausea
Vomiting
Noticed a sudden change in bowel habits that lasts over 2 weeks

OTC - STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

You have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

OTC – IF PREGNANT 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

Take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years of age or older	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	½ tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM
Do not use if imprinted safety seal under cap is missing or damaged.
Store at 25° C (77° F); excursions permitted between 15° C-30° C (59° -86° F).
Keep tightly closed.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, dicalcium phosphate, D&C yellow No 10 Aluminum Lake, ethanol, FD&C yellow No 6 Aluminum Lake, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, talc, 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	2
998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD	2
998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY	2

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0311534090604	GTIN-13: 0311534090604 EAN-13: 0311534090604 GTIN-12: 311534090604 UPC-A: 311534090604 GTIN storage (14 digits): 00311534090604	dda29277-figure-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11534-090-01	2020-01-31	C162847	48780-1	9d75b9d0-134e-f424-e053-dadaa90a57ce	Unknown Title
11534-090-60	2020-01-31	C162847	48780-1	9d75b9d0-134e-f424-e053-dadaa90a57ce	Unknown Title

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11534-090-01	Senna and Docusate Sodium	100 in 1 BOTTLE	TABLET, FILM COATED	100		2
11534-090-60	Senna and Docusate Sodium	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11534-090	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	2	Legacy NDC, 2 package rows	20130807_56c38795-7b35-43bf-900e-07df84d27c14.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11534-090-01	EA - Each	11534-090	ca617f69-d606-4ea3-93f0-b50adb837dc0	1	2019-09-05
11534-090-60	EA - Each	11534-090	cfef015e-222b-493b-aef7-027824600879	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	2
SENNOSIDES	ACTIVE INGREDIENT	3FYP5M0IJX	2
DOCUSATE	ACTIVE MOIETY	M7P27195AG	2
SENNOSIDES	ACTIVE MOIETY	3FYP5M0IJX	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Senna and Docusate Sodium
DOCUSATE SODIUM
DOCUSATE
SENNOSIDES
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SILICON DIOXIDE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POLYETHYLENE GLYCOLS
STARCH, CORN
SODIUM BENZOATE
STEARIC ACID
TITANIUM DIOXIDE
TALC
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11534-090	11534-090-60, 11534-090-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
FD&C YELLOW NO. 6	H77VEI93A8	IACT
D&C YELLOW NO. 10	35SW5USQ3G	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
TALC	7SEV7J4R1U	IACT
ALCOHOL	3K9958V90M	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 · 451 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 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
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
HYPROMELLOSE 2208 (100 MPA.S)	HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	CAPSULE, DELAYED RELEASE / ORAL		630 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SPONGE / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / SUBLINGUAL	0.23 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 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
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER / ORAL		48 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL		2442 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	FILM / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION, EXTENDED RELEASE / ORAL	0.12 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET, EXTENDED RELEASE / ORAL		1036 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, EXTENDED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
HYPROMELLOSE 2208 (100 MPA.S)	HYPROMELLOSE 2208 (100 MPA.S)	B1QE5P712K	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 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
dda29277-e3fb-4563-a038-53838c055ff4			56c38795-7b35-43bf-900e-07df84d27c14	2013-08-07	Warnings	Exact identifier spl id: dda29277-e3fb-4563-a038-53838c055ff4 spl set id: 56c38795-7b35-43bf-900e-07df84d27c14

Reported adverse events (FAERS/openFDA)#

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