senokot

senokot
SPL v12
SPL
SPL Set ID c18dd7fa-993b-440b-8cdd-f1551abb99ca
Route
oral
Published
Effective Date 2023-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (8.6 mg)
Inactive Ingredients
croscarmellose sodium calcium phosphate, dibasic, anhydrous hypromellose, unspecified magnesium stearate maltodextrin cellulose, microcrystalline mineral oil polyethylene glycol, unspecified talc

Identifiers & Packaging

Pill Appearance
Imprint: S Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
otc monograph drug active Since 1956-06-01

Purpose

Laxative

Description

Drug Facts Active ingredient (in each tablet) Sennosides 8.6mg


Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Drug Facts



Active ingredient (in each tablet)

Sennosides 8.6mg

Indications and Usage

Uses

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

Laxative

Dosage and Administration

Directions

  • take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage
adults and children

12 years of age and over
2 tablets oncea day 4 tablets twicea day
children 6 to under12 years 1 tablet once aday 2 tablets twicea day
children 2 to under6 years 1/2 tablet oncea day 1 tablet twicea day
children under2 years ask a doctor ask a doctor
Description

Drug Facts Active ingredient (in each tablet) Sennosides 8.6mg

Section 42229-5

Other Information

  • each tablet contains: calcium 20 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Section 50565-1

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

Section 50566-9

Stop use and ask a doctorif you have rectal bleeding or fail to have a bowel movementafter use of a laxative. These may indicate a serious condition.

Section 50568-5

Aska doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues overa 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, dicalciumphosphate, hypromellose, magnesium stearate, maltodextrin, microcrystallinecellulose, mineral oil, polyethylene glycol, talc

Section 51945-4

50 Tablets

NDC 67618-300-50

100 Tablets

NDC 67618-300-10

Section 53414-9

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Drug Facts



Active ingredient (in each tablet)

Sennosides 8.6mg

Indications and Usage (34067-9)

Uses

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

Laxative

Dosage and Administration (34068-7)

Directions

  • take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage
adults and children

12 years of age and over
2 tablets oncea day 4 tablets twicea day
children 6 to under12 years 1 tablet once aday 2 tablets twicea day
children 2 to under6 years 1/2 tablet oncea day 1 tablet twicea day
children under2 years ask a doctor ask a doctor
Section 42229-5 (42229-5)

Other Information

  • each tablet contains: calcium 20 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctorif you have rectal bleeding or fail to have a bowel movementafter use of a laxative. These may indicate a serious condition.

Section 50568-5 (50568-5)

Aska doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues overa 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, dicalciumphosphate, hypromellose, magnesium stearate, maltodextrin, microcrystallinecellulose, mineral oil, polyethylene glycol, talc

Section 51945-4 (51945-4)

50 Tablets

NDC 67618-300-50

100 Tablets

NDC 67618-300-10

Section 53414-9 (53414-9)

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


Advanced Ingredient Data


Raw Label Data

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