Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 6c8c7c46-3ded-4e89-8e16-30eeb72aa08b
Route
ORAL
Published
Effective Date 2024-06-14
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 2021-06-25

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 over 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 told to do so by a doctor
Product Label
EQUALINE 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, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silcon dioxide, sodium benzoate, stearic acid, titanium dioxide

Questions Or Comments?

Call toll free 1-855-423-2630

Principal Display Panel

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

Stool Softener + Stimulant Laxative

docusate sodium 50 mg/

sennosides 8.6 mg

  • gentle, dependable
  • relief in 6-12 hours

tablets

*This product is not manufactured of distributed by AVrio Health L.P., distributor of Colace® 2-IN1

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

DISTRIBUTED BY: UNFI

PROVIDENCE, RI 02908 USA

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 over 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 told to do so by a doctor
Product Label
EQUALINE Stool Softener
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, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silcon dioxide, sodium benzoate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll free 1-855-423-2630

Principal Display Panel

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

Stool Softener + Stimulant Laxative

docusate sodium 50 mg/

sennosides 8.6 mg

  • gentle, dependable
  • relief in 6-12 hours

tablets

*This product is not manufactured of distributed by AVrio Health L.P., distributor of Colace® 2-IN1

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

DISTRIBUTED BY: UNFI

PROVIDENCE, RI 02908 USA

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

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