SPL v1
SPL
SPL Set ID 2bbb1b99-d43c-40a3-bc53-e18e8394c318
Route
ORAL
Published
Effective Date 2025-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg) Docusate (50 mg)
Inactive Ingredients
Croscarmellose Sodium Silicon Dioxide Anhydrous Dibasic Calcium Phosphate Polyethylene Glycol, Unspecified Fd&c Red No. 40 Aluminum Lake Hypromelloses Cellulose, Microcrystalline Magnesium Stearate Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S44 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-07

Description

Drug Facts


Medication Information

Description

Drug Facts

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

Drug Facts

Section 55105-1

Active ingredients (in each tablet)                    Purpose

Docusate sodium 50 mg.......................................Stool softner

Sennosides 8.6 mg................................................Laxative

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 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

½ tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Do Not Use
  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Other Information
  • each tablet contains: calcium 21 mg, sodium 3 mg. VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, polyethylene glycol, FD&C red 40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid powder, titanium dioxide.

Questions Or Comments?

call toll-free 1-302-380-3408

Principal Display Panel

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.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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.

Structured Label Content

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

Drug Facts

Section 55105-1 (55105-1)

Active ingredients (in each tablet)                    Purpose

Docusate sodium 50 mg.......................................Stool softner

Sennosides 8.6 mg................................................Laxative

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 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

½ 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)
  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Other Information (Other information)
  • each tablet contains: calcium 21 mg, sodium 3 mg. VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, polyethylene glycol, FD&C red 40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid powder, titanium dioxide.

Questions Or Comments? (Questions or comments?)

call toll-free 1-302-380-3408

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.

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 right away.

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

ask a health professional before use.

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.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)