191r Timely 49483 080 Sennosides 8.6 Mg Tablets

191r Timely 49483 080 Sennosides 8.6 Mg Tablets
SPL v7
SPL
SPL Set ID 18ec8127-422c-4c1a-8331-58dabce69969
Route
ORAL
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides A And B (8.6 mg)
Inactive Ingredients
Dibasic Calcium Phosphate Dihydrate Hypromelloses Magnesium Stearate Microcrystalline Cellulose Mineral Oil Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: TCL080 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-05-14

Description

Active ingredient (in each tablet) 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 and over 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

Description

Active ingredient (in each tablet) 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.

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 may indicate a serious condition

Section 50569-3

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Section 50570-1

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

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

Purpose

Laxative

Section 55106-9

Active ingredient (in each tablet)

Sennosides 8.6 mg

Other Information

Other information ­

  • each tablet contains: calcium 25 mg,sodium 2 mg (VERY 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 and over 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

Warnings and Precautions (34071-1)

Warnings

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.

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 may indicate 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 movements that continues over a period of 2 weeks

Section 50570-1 (50570-1)

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

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)

Purpose

Laxative

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Sennosides 8.6 mg

Other Information (OTHER INFORMATION)

Other information ­

  • each tablet contains: calcium 25 mg,sodium 2 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)