Stool Softener And Laxative

Stool Softener And Laxative
SPL v3
SPL
SPL Set ID 39f99d7f-8e7c-40ec-9c32-d14b3d36d8f7
Route
ORAL
Published
Effective Date 2021-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Calcium Phosphate D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Microcrystalline Cellulose Maltodextrin Polyethylene Glycol 400 Water Sodium Benzoate Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S44 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-11-22
Description

Docusate sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Laxative

Medication Information

Purpose

Stool softener



Laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Pouch

Warnings

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Directions

take preferably at bedtime or as directed by a doctor

Age Starting Dosage Maximum Dosage
adults & children 12 years of age & over 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years of age 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

Drug Facts

Distributed By:

Cabinet Health P.B.C.

Other Information

• each tablet contains: calcium 20 mg and sodium 6 mg

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow No. 10, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, maltodextrin, polyethylene glycol 400, purified water, sodium benzoate, stearic acid, titanium dioxide

Questions Or Comments?

1-888-333-9792

Stop Use and Ask A Doctor If

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition • you need to use a stool softener laxative for more than 1 week

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Docusate sodium 50 mg



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

Ask A Doctor Or Pharmacist Before Use

if you are if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Structured Label Content

Uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Pouch

Purpose

Stool softener



Laxative

Warnings

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Directions

take preferably at bedtime or as directed by a doctor

Age Starting Dosage Maximum Dosage
adults & children 12 years of age & over 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years of age 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

Drug Facts

Distributed By: (Distributed by:)

Cabinet Health P.B.C.

Other Information (Other information)

• each tablet contains: calcium 20 mg and sodium 6 mg

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)

Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow No. 10, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, maltodextrin, polyethylene glycol 400, purified water, sodium benzoate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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 could be signs of a serious condition • you need to use a stool softener laxative for more than 1 week

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 medical help or contact a Poison Control Center right away. (1-800-222-1222)

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

Docusate sodium 50 mg



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

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:24.649090 · Updated: 2026-03-14T23:00:49.702127