Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 72f8e8d7-ee38-4bd3-8711-f11fded0cede
Route
ORAL
Published
Effective Date 2024-05-01
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 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Silicon Dioxide Sodium Benzoate Stearic Acid Titanium Dioxide Aluminum Oxide Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Imprint: TCL097 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-31
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 
childrens 6 to under 12 years of age  take1-2 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 now taking mineral oil, unless directed by a doctor
Product Label
QUALITY CHOICE Stool Softener
Other Information
  • each tablet contains: calcium 21mg
  • each tablet contains: sodium 5 mg VERY LOW SODIUM
  • store at 25ºC(77ºF), excursion 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, sillicon dioxide, sodium benzoate, stearic acid, titanium dioxide

Questions Or Comments?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the Active Ingredients in Colace® 2-IN-1

STOOL SOFTENER

Plus Stimulant Laxative

Docusate sodium, 50 mg

Sennosides, 8.6 mg

Effective

Reliable

Comfortable 

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 C.D.M.A. Inc.©

43157 W. 9 Mile Rd

Novi, MI 48375

www.qualitychoice.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 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 
childrens 6 to under 12 years of age  take1-2 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 now taking mineral oil, unless directed by a doctor
Product Label
QUALITY CHOICE Stool Softener
Other Information
  • each tablet contains: calcium 21mg
  • each tablet contains: sodium 5 mg VERY LOW SODIUM
  • store at 25ºC(77ºF), excursion 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, sillicon dioxide, sodium benzoate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the Active Ingredients in Colace® 2-IN-1

STOOL SOFTENER

Plus Stimulant Laxative

Docusate sodium, 50 mg

Sennosides, 8.6 mg

Effective

Reliable

Comfortable 

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 C.D.M.A. Inc.©

43157 W. 9 Mile Rd

Novi, MI 48375

www.qualitychoice.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 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:02.546528 · Updated: 2026-03-14T23:02:53.135799