Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID ebb35e67-4e83-445e-af6e-ecb43b1d3df6
Route
ORAL
Published
Effective Date 2024-08-09
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 Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Silicon Dioxide Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: PSD22 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-30

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Laxative


Medication Information

Purpose

Stool softener

Laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6- 12 hours.
Directions
  • 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
Do Not Use
  • If you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Product Label
QUALITY CHOICE Stool Softener
Other Information
  • 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

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc,  titanium dioxide.

Questions Or Comments?

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

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

Tablets

†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 ID 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 48376-0995

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 Breastfeeding,

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 (1-800-222-1222) 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 continues over a period of 2 weeks.

Structured Label Content

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

Stool softener

Laxative

Directions
  • 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
Do Not Use (Do not use)
  • If you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor
Product Label
QUALITY CHOICE Stool Softener
Other Information (Other information)
  • 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

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc,  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 Senokot-S®

Stool Softener Plus Laxative

Stool Softener • Laxative

Docusate Sodium, 50 mg | Sennosides, 8.6 mg

Provides Gentle Relief of: Occasional Constipation

Tablets

†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 ID 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 48376-0995

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 Breastfeeding, (If pregnant or breastfeeding,)

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 (1-800-222-1222) 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 continues over a period of 2 weeks.

Advanced Ingredient Data


Raw Label Data

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