Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 674bdea5-0bdc-4fbb-a05f-b6c0f7cf1c66
Route
ORAL
Published
Effective Date 2015-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Yellow No. 10 Dextrose Calcium Phosphate, Dibasic, Dihydrate Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycols Silicon Dioxide Sodium Benzoate Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G55 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-07-16
Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Docusate Sodium.............................Stool Softener Sennosides.......................................Laxative

Medication Information

Purpose

Docusate Sodium.............................Stool Softener Sennosides.......................................Laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

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

Purposes

Docusate Sodium.............................Stool Softener

Sennosides.......................................Laxative

Warnings


Directions
  • take preferably at bedtime or as directed by a doctor
age starting dose maximum dose
adults and children 12 years and 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

 1/2 tablet once a day

 1 tablet twice a day
children under 2 years

 ask a doctor

 ask a doctor
Do Not Use
  • if you are now taking mineral oil, unless directed by a doctor

  • laxative products for longer than 1 week unless directed by a doctor

Questions?

If you have any questions or comments,or to report an adverse event, please contact +1 404 256 8817.

Other Information
  • Each tablet contains: Calcium 20 mg
  • Each tablet contains: Sodium   4 mg
  • Store at room temperature
  • Keep lid tightly closed in a dry place

  • Do not use if imprinted seal under cap is broken or missing
  • Tamper Evident: Do not use if sealed blister unit is broken or damaged
Inactive Ingredients

Croscarmellose Sodium, D and C Yellow #10, Dextrose, Dicalcium Phosphate, FD and C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Silica, Sodium Benzoate, Stearic Acid, Titanium Dioxide.

Principal Display Panel

COLISTAT PLUS

Stool Softener and Stimulant Laxative





  • Effective
  • Reliable
  • Comfortable

60 TABLETS







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.

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.

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 continues over a period of 2 weeks

Structured Label Content

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

Purposes

Docusate Sodium.............................Stool Softener

Sennosides.......................................Laxative

Warnings


Directions
  • take preferably at bedtime or as directed by a doctor
age starting dose maximum dose
adults and children 12 years and 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

 1/2 tablet once a day

 1 tablet twice a day
children under 2 years

 ask a doctor

 ask a doctor
Do Not Use (Do not use)
  • if you are now taking mineral oil, unless directed by a doctor

  • laxative products for longer than 1 week unless directed by a doctor

Questions?

If you have any questions or comments,or to report an adverse event, please contact +1 404 256 8817.

Other Information (Other information)
  • Each tablet contains: Calcium 20 mg
  • Each tablet contains: Sodium   4 mg
  • Store at room temperature
  • Keep lid tightly closed in a dry place

  • Do not use if imprinted seal under cap is broken or missing
  • Tamper Evident: Do not use if sealed blister unit is broken or damaged
Inactive Ingredients (Inactive ingredients)

Croscarmellose Sodium, D and C Yellow #10, Dextrose, Dicalcium Phosphate, FD and C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Silica, Sodium Benzoate, Stearic Acid, Titanium Dioxide.

Principal Display Panel

COLISTAT PLUS

Stool Softener and Stimulant Laxative





  • Effective
  • Reliable
  • Comfortable

60 TABLETS







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 use of a laxative.

These may indicate 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.

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 continues over a period of 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:57.993151 · Updated: 2026-03-14T22:54:03.234260