Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 9adaec97-43e3-48f2-96c8-c508b693676c
Route
ORAL
Published
Effective Date 2023-10-05
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 2020-06-30
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
  • relieves ccasional 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 told to do so by a doctor
  • if you are now taking mineral oil, unless told to do so by a doctor
Product Label
CARE ONE Stool Softener and Stimulant Laxative
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, silcon 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 the active ingredients in Colace® 2-IN-1

STOOL SOFTENER & STIMULANT LAXATIVE

Docusate sodium, 50 mg

and Sennosides, 8.6 mg

A GENTLE, PREDICTABLE LAXATIVE

TABLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 • 1-877-846-9949

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 ccasional 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 told to do so by a doctor
  • if you are now taking mineral oil, unless told to do so by a doctor
Product Label
CARE ONE Stool Softener and Stimulant Laxative
Other Information (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, silcon 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 the active ingredients in Colace® 2-IN-1

STOOL SOFTENER & STIMULANT LAXATIVE

Docusate sodium, 50 mg

and Sennosides, 8.6 mg

A GENTLE, PREDICTABLE LAXATIVE

TABLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 • 1-877-846-9949

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: 2026-02-15T12:01:20.815286 · Updated: 2026-03-14T23:01:21.342577