FDA.reportPublic FDA data

Sennosides, Docusate Sodium

Manufacturer
Rugby Laboratories
Effective date
2019-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:07:04

Label at a glance#

ProductSennosides, Docusate Sodium
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections

Indications and uses

for overnight relief from occasional constipation (irregularity)  generally produces bowel movement in 6-12 hours

Dosage and administration

take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and older take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purposes

Stool softener

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

  • for overnight relief from occasional constipation (irregularity) 
  • generally produces bowel movement in 6-12 hours

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

  • laxative products for longer than one week, unless directed by a doctor 
  • if you are now taking mineral oil, unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain 
  • nausea 
  • vomiting 
  • noticed a sudden change in bowel habits that continues over a period of two weeks

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

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.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and older

take 2-4 tablets daily

children 6 to under 12 years of age

take 1-2 tablets daily

children 2 to under 6 years of age

take up to 1 tablet daily

children under 2

ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 11 mg 
  • each tablet contains: sodium 4 mg (VERY LOW SODIUM) 
  • store at 25°C (77°F); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1- 800-645-2158

SPL UNCLASSIFIED SECTION

*Rugby Laboratories is not afliated with the owner of the trademark Colace® 2-IN-1

SAVE CARTON FOR COMPLETE DRUG FACTS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby ®

NDC 0536-1167-01

COMPARE TO THE ACTIVE INGREDIENTS IN COLACE® 2-IN-1.*

Docusate Sodium 50 mg & Senna 8.6 mg

Stimulant Laxative Plus Stool Softener

100 Tablets

3052C-rugby-label3052C-rugby-label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1167-01EA - Each0536-11677ff3a8c9-8da0-49dd-9fde-57a73480aca412019-02-13
0536-1167-10EA - Each0536-1167186b35ae-3428-4b3e-b637-17dd9bc0b31512019-03-12

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-11670536-1167-10, 0536-1167-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURYL SULFATE368GB5141JIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
TALC7SEV7J4R1UIACT
MALTODEXTRIN7CVR7L4A2DIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
STARCH, CORNO8232NY3SJIACT
SODIUM BENZOATEOJ245FE5EUIACT
LIGHT MINERAL OILN6K5787QVPIACT
MAGNESIUM STEARATE70097M6I30IACT
TRIACETINXHX3C3X673IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40WZB9127XOAIACT
SENNOSIDES3FYP5M0IJXACTIB
HYPROMELLOSES3NXW29V3WOIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
95213cd4-d08c-4400-e053-2995a90ad49079006a7f-9c25-0530-e053-2a91aa0a8ffe2019-10-17WarningsExact identifier
spl id: 95213cd4-d08c-4400-e053-2995a90ad490
spl set id: 79006a7f-9c25-0530-e053-2a91aa0a8ffe

Reported adverse events (FAERS/openFDA)#

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