Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 9c986ca8-d540-49c1-b092-94c1bf837c07
Route
ORAL
Published
Effective Date 2024-05-09
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 Aluminum Oxide

Identifiers & Packaging

Pill Appearance
Imprint: PSD22 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-31

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 produces 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 or over 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 Labeling
QUALITY CHOICE Stool Softener plus Laxative
Other Information
  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 mg LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
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 Atlantis Consumer Healthcare Inc., distributor 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 CDMA, Inc.

Novi, MI 48375

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 (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 periodof 2 weeks 

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces 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 or over 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 Labeling
QUALITY CHOICE Stool Softener plus Laxative
Other Information (Other information)
  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 mg LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients (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 Atlantis Consumer Healthcare Inc., distributor 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 CDMA, Inc.

Novi, MI 48375

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 (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 periodof 2 weeks 

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)