Stool Softener plus Laxative

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2023-05-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:31:30

Label at a glance#

ProductStool Softener plus Laxative
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces  bowel movement in 6- 12 hours.

Dosage and administration

Take preferably at bedtime or as directed by a doctor  age  starting dosage  maximum dosage  adults and children 12 years of age and older  2 tablets once a day  4 tablets twice a day  children 6 to under 12 years  1 tablet once a day  2 tablets twice a day  children 2 to under 6 years  1/2 tablet once a day  1 tablet twice a day  children under 2 years  ask a doctor  ask a doctor

Storage and handling

each tablet contains: calcium 30 mg each tablet contains : sodium 6 mg LOW SODIUM store at 25ºC (77º); excursions permitted between 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Laxative

Purpose

OTC - PURPOSE SECTION

Stool softener

laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces  bowel movement in 6- 12 hours.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • If you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take preferably at bedtime or as directed by a doctor

 age

 starting dosage maximum dosage
 adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day
 children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
 children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
 children under 2 years ask a doctor ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 mg LOW SODIUM
  • store at 25ºC (77º); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, stearic acid, talc* titanium dioxide.
*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

**Compare to the Active Ingredients in Senokot-S®

Stool Softener plus laxative

Stool Softener • Laxative

Docusate Sodium, 50 mg | Sennosides, 8.6 mg

Provides Gentle Relief of: Occasional Constipation

Tablet

**This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot-S®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by C.D.M.A., Inc.©

43157 W. 9 Mile Rd

Novi, MI 48376

www.qualitychoice.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE Stool Softener
QUALITY CHOICE Stool Softener

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-87463868-874-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c539cb1c-64cf-4106-a89c-9555f2a76a8ada85418c-bf37-42b7-874f-3a2318d0863c2023-05-11WarningsExact identifier
spl id: c539cb1c-64cf-4106-a89c-9555f2a76a8a
spl set id: da85418c-bf37-42b7-874f-3a2318d0863c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.