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
Purpose

Stool softener Laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Medication Information

Warnings

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

Uses

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

Purpose

Stool softener



Laxative

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

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

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Pouch

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.

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

Warnings

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

Uses

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

Purpose

Stool softener



Laxative

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

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

Pouch

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.

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