Senna

Senna
SPL v3
SPL
SPL Set ID 737ec163-f07c-c3b3-e053-2a91aa0a245c
Route
ORAL
Published
Effective Date 2018-08-01
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 Croscarmellose Magnesium Stearate Cellulose, Microcrystalline Mineral Oil Hypromellose, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: TCL;080 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-08-01

Description

Drug Facts

Purpose

Stimulant Laxative


Medication Information

Purpose

Stimulant Laxative

Description

Drug Facts

Uses
  • relieves occasional constipation (irregulatiry)
  • generally causes bowel movement in 6-12 hours
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach 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 51945-4

NDC 69618-018-01

Reliable-1® LABORATORIES

Micro-Coated

Senna

Sennosides 8.6 mg

(standardized senna concentrate)

NATURAL VEGETABLE LAXATIVE

100 TABLETS

*Compare to the Active Ingredient in SENOKOT®

Section 53414-9

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

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
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 does until you are comfortable

Age starting dosage maximum dosage
adults 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 tabelts 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 25 mg, sodium 2 mg (VERY LOW SODIUM)
  • store at 25°c (77°F) excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

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

Questions Or Comments?

Call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredients (in Each Tablet)

Sennosides 8.6 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregulatiry)
  • generally causes bowel movement in 6-12 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach 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 51945-4 (51945-4)

NDC 69618-018-01

Reliable-1® LABORATORIES

Micro-Coated

Senna

Sennosides 8.6 mg

(standardized senna concentrate)

NATURAL VEGETABLE LAXATIVE

100 TABLETS

*Compare to the Active Ingredient in SENOKOT®

Section 53414-9 (53414-9)

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

Purpose

Stimulant Laxative

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
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 does until you are comfortable

Age starting dosage maximum dosage
adults 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 tabelts 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 25 mg, sodium 2 mg (VERY LOW SODIUM)
  • store at 25°c (77°F) excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)