drug facts

drug facts
SPL v4
SPL
SPL Set ID 9467e1f7-19bb-4fb3-853b-75c4d28bb9a9
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
carnauba wax croscarmellose sodium dibasic calcium phosphate dihydrate fd&c blue no. 2 hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified silicon dioxide sodium benzoate stearic acid talc titanium dioxide aluminum oxide fd&c red no. 40

Identifiers & Packaging

Pill Appearance
Imprint: TCL097;PSD21;S44 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2018-12-31

Purpose

Stool softener Stimulant laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg


Medication Information

Uses
  • for overnight relief from 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


Other Information
  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 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 blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, sillicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Description

Docusate sodium 50 mg Sennosides 8.6 mg

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

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 Plus Stimulant Laxative
Questions Or Comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

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
  • for overnight relief from 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


Other Information
  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 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 blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, sillicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

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

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 Plus Stimulant Laxative
Questions Or Comments? (Questions or comments?)

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

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

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