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

Purpose

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

Description

Docusate Sodium 50 mg Sennosides 8.6 mg


Medication Information

Warnings


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

Purpose

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

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

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.

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Principal Display Panel

COLISTAT PLUS

Stool Softener and Stimulant Laxative





  • Effective
  • Reliable
  • Comfortable

60 TABLETS







Questions?

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

Purposes

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

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

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

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

Warnings


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

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

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







Questions?

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

Purposes

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

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

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

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)