SPL v2
SPL
SPL Set ID cebc1e10-7dc7-489f-a8f6-dac88a0f2b81
Route
ORAL
Published
Effective Date 2025-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg)
Inactive Ingredients
Lactose Monohydrate Microcrystalline Cellulose Crospovidone, Unspecified Povidone K30 Magnesium Stearate Polyvinyl Alcohol Polysorbate 80 Polyethylene Glycol, Unspecified Talc

Identifiers & Packaging

Pill Appearance
Imprint: CS Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-05

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 50565-1

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. 

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

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

Lactose Monohydrate, Microcrysatlline Cellulose, Crosspovidone XL 10, PVP K30, Magnesium Stearate. Aqua Dry Clear contains: Polyvinyl alcohol, Polysorbate 80, Macrogol/PEG, Talc

Questions Or Comments?

Call + 1-732-994-2808 or email [email protected]

Ndc 72090 041 01 (300ct Bottle)

Ndc 72090 041 02 (600ct Bottle)

Active Ingredient (in Each Tablet)

Sennosides 8.6 mg


Structured Label Content

Uses:
  • relieves occasional constipation (irregularity).
  • generally prodcues a bowel movement in 6-12 hours
Section 50565-1 (50565-1)

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. 

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

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)

Lactose Monohydrate, Microcrysatlline Cellulose, Crosspovidone XL 10, PVP K30, Magnesium Stearate. Aqua Dry Clear contains: Polyvinyl alcohol, Polysorbate 80, Macrogol/PEG, Talc

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call + 1-732-994-2808 or email [email protected]

Ndc 72090 041 01 (300ct Bottle) (NDC 72090-041-01 (300ct Bottle))

Ndc 72090 041 02 (600ct Bottle) (NDC 72090-041-02 (600ct Bottle))

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

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)