FDA.reportPublic FDA data

Stimulant Laxative Plus Stool Softener

Manufacturer
RUGBY LABORATORIES | Pharbest Pharmaceuticals, Inc.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:48:06

Label at a glance#

ProductStimulant Laxative Plus Stool Softener
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a bowel movement in 6 to 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 over 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 upto 1 tablet daily children under 2  ask a doctor

Storage and handling

each tablet contains:  calcium 10 mg, sodium 5 mg, Very Low Sodium store at 20-25°C (68-77°F); excursions permitted between 15-30 o C (59-86 o F). Keep tightly closed. 

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after the use of a laxative.

These could be sings of a serious condition.

If pregnant or breast-feeding,

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 (1-800-222-1222).

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 over

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 upto 1 tablet daily

children under 2 

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
  • store at 20-25°C (68-77°F); excursions permitted between 15-30oC (59-86oF). Keep tightly closed. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RUGBY®

NDC 0536-1248-10

Compare to the

active ingredients

in Colace® 2-IN-1*

Stimulant

Laxative

Plus Stool Softener

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

50 mg/ 8.6 mg

1000 TABLETS

Rugby Stimulant Laxative Plus Stool Softener Tablet 1000 ct. Product LabelRugby Stimulant Laxative Plus Stool Softener Tablet 1000 ct. Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN3
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD3
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1248-01Stimulant Laxative Plus Stool Softener100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
0536-1248-10Stimulant Laxative Plus Stool Softener1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1248STIMULANT LAXATIVE PLUS STOOL SOFTENER (DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG) TABLET, FILM COATED [RUGBY LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20241222_f5afd8eb-d35d-44ab-897d-1d41c98ca138.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1248-01EA - Each0536-124808914e23-fb7a-4b54-984a-a846bc8e77b912020-02-13
0536-1248-10EA - Each0536-1248b50e2bcb-0359-4534-98b7-3d9ed55f256612020-01-03

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12480536-1248-01, 0536-1248-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SODIUM BENZOATEOJ245FE5EUIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGRUGBY LABORATORIESf5afd8eb-d35d-44ab-897d-1d41c98ca1382024-12-19WarningsExact identifier
ndc (package): 0536-1248-10
ndc (package): 0536-1248-01
ndc (product): 0536-1248
ndc11 (package): 00536124801
ndc11 (package): 00536124810
spl id: 5c8f314a-16ca-4856-9cd1-f6760cd938a5
spl set id: f5afd8eb-d35d-44ab-897d-1d41c98ca138

Reported adverse events (FAERS/openFDA)#

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