Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d
Route
ORAL
Published
Effective Date 2024-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: TCL097 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-30
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
  • for overnight relief from occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 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 told to do so by a doctor
  • if you are presently taking mineral oil, unless directed by a doctor
Product Label
SIGNATURE CARE Stool Softener
Other Information
  • each tablet contains: calcium 21 mg
  • each tablet contains: sodium 5 mg VERY LOW SODIUM
  • store at 25ºC(77ºF);excursions permitted between 15-30ºC(59-86ºF)
Inactive Ingredients

carnauba wax,  croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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

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.

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
  • for overnight relief from 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 
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 directed by a doctor
Product Label
SIGNATURE CARE Stool Softener
Other Information
  • each tablet contains: calcium 21 mg
  • each tablet contains: sodium 5 mg VERY LOW SODIUM
  • store at 25ºC(77ºF);excursions permitted between 15-30ºC(59-86ºF)
Inactive Ingredients (Inactive ingredients)

carnauba wax,  croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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

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.

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: 2026-02-15T12:03:06.175689 · Updated: 2026-03-14T23:02:57.214195