drug facts

drug facts
SPL v4
SPL
SPL Set ID ae2c7300-f9c4-43b5-9f8e-30f2e7d17635
Route
oral
Published
Effective Date 2024-09-09
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 2021-01-29
Purpose

Stool softener Stimulant laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Medication Information

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 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 
Other Information
  • each tablet contains: calcium 300 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, sillicon dioxide, talc, titanium dioxide

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Principal Display Panel

Compare to Colace® 2-IN-1  active ingredients*

Stool Softener

Plus Stimulant Laxative

DOCUSATE SODIUM 50 mg

SENNOSIDES 8.6 mg

For overnight relief of occasional constipation

  • Gentle 
  • Dependable

Relief in 6-12 hours

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

BETTER LIVING BRANDS LLC, P.O. BOX 99

PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

Do Not Use
  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor
Product Label
SIGNATURECARE Stool Softener Laxative
Questions Or Comments?

Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

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 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 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 
Other Information
  • each tablet contains: calcium 300 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, sillicon dioxide, talc, titanium dioxide

Principal Display Panel

Compare to Colace® 2-IN-1  active ingredients*

Stool Softener

Plus Stimulant Laxative

DOCUSATE SODIUM 50 mg

SENNOSIDES 8.6 mg

For overnight relief of occasional constipation

  • Gentle 
  • Dependable

Relief in 6-12 hours

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

BETTER LIVING BRANDS LLC, P.O. BOX 99

PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

Do Not Use (Do not use)
  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor
Product Label
SIGNATURECARE Stool Softener Laxative
Questions Or Comments? (Questions or comments?)

Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

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 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:33.096378 · Updated: 2026-03-14T23:03:41.436909