Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID f5afd8eb-d35d-44ab-897d-1d41c98ca138
Route
ORAL
Published
Effective Date 2024-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg) Docusate (50 mg)
Inactive Ingredients
Croscarmellose Sodium Calcium Phosphate, Dibasic, Dihydrate Fd&c Red No. 40 Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Sodium Benzoate Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: PH32 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-22

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Stimulant laxative


Medication Information

Purpose

Stool softener

Stimulant laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6 to 12 hours
Section 51945-4

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

Directions
  • 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

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
Other Information
  • 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

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

Questions Or Comments?

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

Stop Use and Ask A Doctor If

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,

ask a health professional before use. 

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredients (in Each Tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6 to 12 hours
Section 51945-4 (51945-4)

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

Purpose

Stool softener

Stimulant laxative

Directions
  • 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

Do Not Use (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
Other Information (Other information)
  • 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 ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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, (If pregnant or breast-feeding,)

ask a health professional before use. 

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredients (in Each Tablet) (Active Ingredients (in each tablet))

Docusate Sodium 50 mg

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)