SPL v1
SPL
SPL Set ID af36e020-0e6f-40b3-b521-25b60e324116
Route
ORAL
Published
Effective Date 2025-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg)
Inactive Ingredients
Maltodextrin Cellulose, Microcrystalline Croscarmellose Sodium Stearic Acid Silicon Dioxide Magnesium Stearate Hypromelloses Sodium Lauryl Sulfate Dibasic Calcium Phosphate Dihydrate Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: S8 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Drug Facts

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Drug Facts

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours
Section 42229-5

Drug Facts

Directions
  • take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage
adults and children 12 years of age or 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 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor

Do Not Use
  • laxative products for longer than 1 week unless directed by a doctor
Questions?

call toll free 1-844-912-4012

Other Information
  • each tablet contains:calcium 25 mg
  • store at room temperature
Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, liquid paraffin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate, stearic acid.

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medial help or contact a Poison Control Center (1-80-222-1222) right away.

Active Ingredient (in Each Tablet)

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks
Principal Display Panel Shipping Label


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours
Section 42229-5 (42229-5)

Drug Facts

Purpose

Laxative

Directions
  • take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage
adults and children 12 years of age or 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 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor

Do Not Use (Do not use)
  • laxative products for longer than 1 week unless directed by a doctor
Questions?

call toll free 1-844-912-4012

Other Information (Other information)
  • each tablet contains:calcium 25 mg
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, hypromellose, liquid paraffin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate, stearic acid.

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medial help or contact a Poison Control Center (1-80-222-1222) right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks
Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)