Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID b23e53d4-fd7d-452d-a851-35a143b6dcb4
Route
ORAL
Published
Effective Date 2024-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Silicon Dioxide Talc Titanium Dioxide Aluminum Oxide Fd&c Blue No. 2

Identifiers & Packaging

Pill Appearance
Imprint: PSD21 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-31
Description

Docusate sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Stimulant laxative

Medication Information

Purpose

Stool softener

Stimulant laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to12 hours
Directions
  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
adults and children 12 years and older take 2-4 tablets daily 
children 6 to under 12 years of age take 1-2 tablets daily 
children 2 to under 6 years of age  take up to 1 tablet daily 
children under 2  ask a doctor 


Do Not Use
  • laxative products for longer than 1 week unless directed  by a doctor
  • if you are presently taking mineral oil, unless directed by a doctor
Product Label
FOSTER & THRIVE Stool Softener
Other Information
  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc, titanium dioxide

Questions Or Comments?

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENTS*

Stool Softener

Docusate sodium 50 mg

Sennosides 8.6 mg

STOOL SOFTENER

STIMULANT LAXATIVE

TABLETS

*This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by: McKesson Corp.,

via SSSl, Memphis, TN 38141

www.fosterandthrive.com

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.

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.

Active Ingredients (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 lasts over a period of 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to12 hours
Purpose

Stool softener

Stimulant laxative

Directions
  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
adults and children 12 years and older take 2-4 tablets daily 
children 6 to under 12 years of age take 1-2 tablets daily 
children 2 to under 6 years of age  take up to 1 tablet daily 
children under 2  ask a doctor 


Do Not Use (Do not use)
  • laxative products for longer than 1 week unless directed  by a doctor
  • if you are presently taking mineral oil, unless directed by a doctor
Product Label
FOSTER & THRIVE Stool Softener
Other Information (Other information)
  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENTS*

Stool Softener

Docusate sodium 50 mg

Sennosides 8.6 mg

STOOL SOFTENER

STIMULANT LAXATIVE

TABLETS

*This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by: McKesson Corp.,

via SSSl, Memphis, TN 38141

www.fosterandthrive.com

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.

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.

Active Ingredients (in Each Tablet) (Active ingredients (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 lasts over a period of 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:15.282293 · Updated: 2026-03-14T23:03:14.317302