SPL v4
SPL
SPL Set ID ac8b602a-e53c-0b44-e053-2a95a90affa8
Route
ORAL
Published
Effective Date 2023-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg)
Inactive Ingredients
Sodium Lauryl Sulfate Microcrystalline Cellulose Silicon Dioxide Stearic Acid D7 Paraffin Dibasic Calcium Phosphate Dihydrate Hypromelloses Magnesium Stearate Maltodextrin Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: none Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-03

Description

Sennosides 8.6 mg

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Sennosides 8.6 mg

Uses:
  • relieves occasional constipation (irregularity).
  • generally prodcues a bowel movement in 6-12 hours
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 habits that continues over a period of 2 weeks.
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.

age

starting dosage

maximum dosage

adults & children 12 years of age 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

Active Ingredient

Sennosides 8.6 mg

Other Information
  • store at 20-25°C (68-77°F) excursions permitted between15°-30°C (59°-86°F)
  • each tablet contains: Calcium 25 mg & sodium 3 mg
Inactive Ingredients

Colloidal silicon dioxide,croscarmellose sodium, Dicalcium phosphate, Hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, Maltodextrin, Purified water, Sodium lauryl sulphate, Stearic Acid.

Questions Or Comments?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST 

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 


Structured Label Content

Uses:
  • relieves occasional constipation (irregularity).
  • generally prodcues a bowel movement in 6-12 hours
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 habits that continues over a period of 2 weeks.
Section 53414-9 (53414-9)

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

Purpose

Laxative

Warnings:

Do not use

  • Laxative products for longer than 1 week, unless directed by a doctor.
Directions (DIRECTIONS)
  • Take preferably at bedtime or as directed by a doctor.

age

starting dosage

maximum dosage

adults & children 12 years of age 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

Active Ingredient

Sennosides 8.6 mg

Other Information (OTHER INFORMATION)
  • store at 20-25°C (68-77°F) excursions permitted between15°-30°C (59°-86°F)
  • each tablet contains: Calcium 25 mg & sodium 3 mg
Inactive Ingredients (INACTIVE INGREDIENTS)

Colloidal silicon dioxide,croscarmellose sodium, Dicalcium phosphate, Hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, Maltodextrin, Purified water, Sodium lauryl sulphate, Stearic Acid.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST 

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)