af36e020-0e6f-40b3-b521-25b60e324116

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

Purpose

Laxative

Description

Drug Facts


Medication Information

Active Ingredient

Sennosides 8.6 mg

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

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.

Description

Drug Facts

Questions?

call toll free 1-844-912-4012

Section 42229-5

Drug Facts

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

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

Active Ingredient (Active ingredient (in each tablet))

Sennosides 8.6 mg

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

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.

Questions?

call toll free 1-844-912-4012

Section 42229-5 (42229-5)

Drug Facts

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

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

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