192r Timely 49483 081 Docusate Sodium 50 Mg Sennosides 8.6 Mg Tablets

192r Timely 49483 081 Docusate Sodium 50 Mg Sennosides 8.6 Mg Tablets
SPL v5
SPL
SPL Set ID dc491692-8d3a-4ccd-a17d-4c630f122595
Route
ORAL
Published
Effective Date 2012-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides A And B (8.6 min)
Inactive Ingredients
Carnauba Wax Silicon Dioxide D&c Yellow No. 10 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol Sodium Benzoate Stearic Acid Titanium Dioxide Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate

Identifiers & Packaging

Pill Appearance
Imprint: TCL081 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-05-14
Description

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

Medication Information

Warnings and Precautions

Warnings



Indications and Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours
Dosage and Administration

Directions

  • take preferably at bedtime or as directed by a doctor.
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
age starting dosage maximum dosage
adults and children 12 years of age 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 ½ tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor
Description

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

Section 50565-1

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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
  • a sudden change in bowel movements that persists over 2 weeks
Section 50570-1

Do not use

  • this product if you are presently taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yellow #6 aluminum 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 55106-9

Active ingredients (in each tablet)

Docustate sodium 50 mg

Sennosides 8.6 mg

Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours
Dosage and Administration (34068-7)

Directions

  • take preferably at bedtime or as directed by a doctor.
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
age starting dosage maximum dosage
adults and children 12 years of age 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 ½ tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor
Warnings and Precautions (34071-1)

Warnings



Section 50565-1 (50565-1)

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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
  • a sudden change in bowel movements that persists over 2 weeks
Section 50570-1 (50570-1)

Do not use

  • this product if you are presently taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yellow #6 aluminum 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 55106-9 (55106-9)

Active ingredients (in each tablet)

Docustate sodium 50 mg

Sennosides 8.6 mg

Section 60561-8 (60561-8)

Other information

  • each tablet contains: calcium 20 mg, sodium 6 mg (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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:31.567791 · Updated: 2026-03-14T23:07:28.673990