209r tcl laxative docusate sodium 50 mg sennosides 8.6 mg tablets

209r tcl laxative docusate sodium 50 mg sennosides 8.6 mg tablets
SPL v3
SPL
SPL Set ID 0ad617e0-10a6-44fa-be62-4f3cc725fb01
Route
oral
Published
Effective Date 2012-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (8.6 mg) docusate (50 mg)
Inactive Ingredients
carnauba wax silicon dioxide croscarmellose sodium dibasic calcium phosphate dihydrate fd&c red no. 40 aluminum lake hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol 400 sodium benzoate stearic acid titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL097 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2010-01-01

Description

Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg


Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Indications and Usage

Uses

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

Dosage and Administration

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 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 years: ask a doctor

Description

Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg

Section 50565-1

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).

Section 50566-9

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

Section 50569-3

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1

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
Section 51727-6

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD & C red #40 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments?

call 1-877-290-4008

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Stool softener

Stimulant laxative

Section 60561-8

Other Information

  • each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

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 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 years: ask a doctor

Section 50565-1 (50565-1)

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).

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD & C red #40 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

call 1-877-290-4008

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Stool softener

Stimulant laxative

Section 60561-8 (60561-8)

Other Information

  • each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)